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RENAL ASSOCIATION CLINICAL PRACTICE GUIDELINES: PROTEIN ENERGY WASTING IN CHRONIC KIDNEY DISEASE UK Renal Association Draft Version: May 2016 Review Date: May 2019 Dr Mark Wright MB,ChB, MD, FRCP Consultant Nephrologist, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, LS9 7TF Mrs Elizabeth Southcott BSc (Hons) Senior Specialist Renal Dietician, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, LS9 7TF Endorsements Please send feedback on this draft to Dr Mark Wright at [email protected] Mrs Elizabeth Southcott at [email protected] 1 Conflicts of Interest Dr Mark Wright has received no sponsorship or funding in relation to the production of these guidelines and they have no financial interests or relationships with any pharmaceutical company. Mrs Elizabeth Southcott has received no sponsorship or funding in relation to the production of these guidelines and they have no financial interests or relationships with any pharmaceutical company. Contents Introduction 3 Summary of Clinical Practice Guidelines 3 1. 2. 3. 4. Screening for protein energy wasting in CKD (Guidelines 1.1- 1.2) Prevention of protein energy wasting in CKD (Guidelines 2.1- 2.6) Treatment of established protein energy wasting in CKD (Guidelines 3.1 - 3.6) Nutritional management of in-patients with stage IV-V CKD (Guidelines 4.14.3) Summary of Audit Measures 8 Audit measures 1-3 Rationale for Clinical Practice Guidelines 1. 2. 3. 4. 9 Screening for protein energy wasting in CKD (Guidelines 1.1- 1.2) Prevention of protein energy wasting in CKD (Guidelines 2.1- 2.6) Treatment of established protein energy wasting in CKD (Guidelines 3.1 - 3.6) Nutritional management of in-patients with stage IV-V CKD (Guidelines 4.14.3) 2 Introduction This document replaces the guideline entitled “Nutrition in CKD” that was published in 2010. There has been discussion about the terminology used in this area in the intervening years. Malnutrition describes both over and undernutrition, so it has been suggested by the International Society of Renal Nutrition and Metabolism (ISRNM), that the term protein energy wasting (PEW) is used to describe the undernutrition that is prevalent in renal failure populations1. It seems reasonable to apply this term in these guidelines as well. Protein energy wasting in chronic kidney disease (CKD) is common but is often undiagnosed. It is a more frequent finding in established renal failure (present in 1875% of patients)1 and is associated with reduced survival. This evidence-based clinical practice guideline summarises the main interventions that may be helpful in the prevention, early identification and management of PEW in this patient population. We reviewed the existing ISRNM, ESPEN and EDTA statements on the assessment of undernutrition in renal patients2-4 and examined the primary sources as appropriate. The broader literature in this field was searched on a number of occasions through 2015 as we revised this document. We have reinterpreted the available data and considered UK Department of Health initiatives on undernutrition5and the UK National Institute of Clinical Excellence (NICE) Quality Standard 24 (QS24) on nutrition support in adults6 in order to produce these guidelines and audit standards. We have revised our recommended audit measures and added a section that gives some guidance about managing nutritional issues when people with renal failure need to be in hospital. References 1. 2. 3. 4. 5. 6. Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler ATA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevinho-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for proteinenergy wasting in acute and chronic disease. Kidney Int 2008; 73, 391-398. Ikizler TA, Cano N, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AYM, Wanner C. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int 2013; 84, 1096-1107. Denis Fouque, Marianne Vennegoor, Piet Ter Wee, Christoph Wanner, Ali Basci, Bernard Canaud, Patrick Haage, Klaus Konner, Jeroen Kooman, Alejandro Martin-Malo, Lucianu Pedrini, Francesco Pizzarelli, James Tattersall, Jan Tordoir, and Raymond Vanholder EBPG Guideline on nutrition Nephrol. Dial. Transplant., May 2007; 22: ii45 - ii87 Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W, Kuhlmann M, Mann H, Horl WH, ESPEN guidelines on enteral nutrition: adult renal failure. Clin Nutr 2006; 25, 295-310. Department of Health. Improving nutritional care: a joint action plan from the Department of Health and Nutrition Summit stakeholders 2007 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitala sset/dh_079932.pdf National Institute of Clinical Excellence. Quality Standard 24 (QS24) Nutrition support in adults (2012). http://publications.nice.org.uk/nutrition-support-in-adults-qs24/list-of-qualitystatementsSummary of clinical practice guidelines for protein energy wasting in CKD 3 1. Screening for protein energy wasting in CKD Guideline 1.1.1 – Screening methods for protein energy wasting in CKD We recommend that all patients with stage 4-5 CKD should have the following parameters measured as a minimum in order to identify PEW (1C): o Unintentional reduction in oedema free body weight (of 5% or more in 3 months or 10% or more in 6 months) o BMI (<20kg/m2) o A report of a reduced dietary intake Guideline 1.1.2 – Additional methods for assessment of protein energy wasting in CKD We suggest that other measures including subjective global assessment, bioimpedance analysis, anthropometry, handgrip strength and assessment of nutrient intake can help to further assess nutritional status in those who are at risk of developing protein energy wasting (2B) Guideline 1.2 – Frequency of screening for protein energy wasting in CKD We recommend that screening should be performed (1D); o o o o o 2. On admission then weekly for inpatients 2-3 monthly for outpatients with eGFR <20 but not on dialysis Within 6-8 weeks of dialysis commencement 3 monthly for stable haemodialysis patients 3 monthly for stable peritoneal dialysis patients Prevention of protein energy wasting in CKD (Guidelines 2.1 – 2.6) Guideline 2.1 – Dose of small solute removal to prevent protein energy wasting We recommend that dialysis dose meets recommended solute clearance index guidelines (e.g. URR, Kt/V) (1C) Guideline 2.2 – Correction of metabolic acidosis and protein energy wasting We recommend that venous bicarbonate concentrations should be maintained above 22 mmol/l (1C) Guideline 2.3 – Minimum daily dietary protein intake We suggest a minimum prescribed protein intake of: o 0.75-1.0 g/kg IBW/day for patients with stage 4-5 CKD not on dialysis 4 o 1.2 g/kg IBW/day for patients treated with dialysis (2B) Guideline 2.4 – Recommended daily energy intake We suggest a prescribed energy intake of o 30-40 kcal/kg IBW/day for all patients depending upon age and physical activity (2B). Guideline 2.5 – Vitamin supplementation in dialysis patients We recommend that haemodialysis patients should be prescribed supplements of water soluble vitamins (1C). Guideline 2.6 – Exercise programs in dialysis patients We recommend that haemodialysis patients should be given the opportunity to participate in regular exercise programmes (1C). 3. Treatment of established protein energy wasting in CKD (Guidelines 3.1 – 3.6) Guideline 3.1 – General treatment of established protein energy wasting We recommend assessment by a physician to determine and treat possible underlying causes and by a specialist dietician to individualise dietary advice (1D) Guideline 3.2 – Oral nutritional supplements (ONS) in established protein energy wasting We recommend the use of oral nutritional supplements if oral intake is below the levels indicated above and food intake is not likely to improve following dietetic assessment / intervention (1C) Guideline 3.3 – Enteral feeding in established protein energy wasting We recommend that the use of enteral feeding via a Naso Gastric tube (NGT) / Percutaneous Endoscopic Gastrostomy (PEG) is considered in selected cases if nutrient intake is suboptimal despite oral supplements recognising that there are significant risks and inconvenience associated with these forms of feeding (1C). It is important to consider the patient’s comorbidity, general condition and likely survival prospects before embarking upon invasive treatment such as this. Guideline 3.4 – Parenteral nutritional support in established protein energy wasting We suggest intradialytic parenteral nutrition (IDPN) or intraperitoneal amino acids may be considered for selected cases (2D) 5 Guideline 3.5 – Anabolic agents in established protein energy wasting We recommend that anabolic agents such as androgens, growth hormone or IGF-1. are not indicated in the treatment of protein energy wasting in adults at this time (1D) Guideline 3.6 – Supplementation of micronutrients in established protein energy wasting While deficiencies of fat soluble vitamins, trace elements and carnitine are prevalent in patients with chronic kidney disease, current evidence does not support either preventative or therapeutic supplementation. 4. Nutritional management of in-patients with stage IV-V CKD Guideline 4.1 - Patients with acute kidney injury We support the comments made about nutritional management of AKI in the Renal Association AKI guideline document. Guideline 4.2 - CKD patients with intercurrent illness We recommend that this patient group is screened on admission to hospital and a nutritional care plan constructed that takes account of their risk. Re-screening should be carried out at weekly intervals. Early referral to specialist dietitians is important in this group. Guideline 4.3 - Refeeding syndrome We recommend that a patient is assessed in order to establish the risk of re-feeding syndrome. A patient will be at risk of re-feeding syndrome if they display: Any one of the following: BMI<16kg/m2 Weight loss of >15% over 3-6/12 Poor intake for 10 days Low Potassium, Phosphate or Magnesium Any two of the following: BMI<18.5kg/m2 Weight loss >10% over 3-6/12 Poor intake for 5 days A history of alcohol abuse or the use of insulin, chemotherapy, antacids or diuretics At extremely high risk of refeeding syndrome: BMI <14kg/m2 Very little or no nutrition for >15 days 6 . If the patient is at risk of re-feeding syndrome we recommend that vitamin B (eg Vitamin B co strong 2 tablets tds) and thiamine supplements (100mg tds) should be prescribed for 10 days. We recommend that potassium, phosphate and magnesium levels should be monitored daily when nutritional support commences. These should be supplemented according to BAPEN guidelines (explained further below). 7 Summary of Audit Measures: 1. The service should be able to produce a list of patients with stage V CKD that have: Weight loss >5% in the preceding 3 months Weight loss > 10% in the preceding 6 months BMI < 20kg/m2 Reduced reported dietary intake at most recent screening 2. The service should be able to demonstrate that these patients were assessed by a dietitian with specialist nephrology experience and a doctor within 4 weeks of being identified as “at risk”. 3. The dialysis service should be able to evidence that food is available for haemodialysis patients when they are receiving their treatment. 8 Rationale for clinical practice guidelines for protein energy wasting in CKD 1. Screening for protein energy wasting in CKD (Guidelines 1.1 – 1.2) Guideline 1.1.1 – Screening methods for protein energy wasting in CKD We recommend that all patients with stage 4-5 CKD should have the following parameters measured as a minimum in order to identify PEW (1C): o Reduction in oedema free body weight (of 5% or more in 3 months or 10% or more in 6 months) o BMI (<20kg/m2) o A report of a reduced dietary intake. These parameters have been associated with increased mortality or other adverse outcomes Guideline 1.1.2 – Additional methods for assessment of protein energy wasting in CKD We suggest that other measures including subjective global assessment, bioimpedance analysis, anthropometry, handgrip strength and assessment of nutrient intake can help to further assess nutritional status in those who are at risk of developing protein energy wasting (2B) Guideline 1.2 – Frequency of screening for protein energy wasting in CKD We recommend that screening should be performed (1D) o o o o o On admission then weekly for inpatients 2-3 monthly for outpatients with eGFR <20 but not on dialysis Within 6-8 weeks of dialysis commencement 3 monthly for stable haemodialysis patients 3 monthly for stable peritoneal dialysis patients Audit Measures 1. The service should be able to produce a list of patients with stage V CKD that have: a. Weight loss >5% in the preceding 3 months b. Weight loss > 10% in the preceding 6 months c. BMI < 20kg/m2 d. Reduced reported dietary intake at most recent screen 9 2. The service should be able to demonstrate that these patients were assessed by a dietitian with specialist nephrology experience and a doctor within 4 weeks of being identified as “at risk”. 3. The dialysis service should be able to evidence that food is available for haemodialysis patients when they are receiving their treatment. Rationale of screening for protein energy wasting in CKD (1.1-1.2 and Audit Measures 1-3) Given that protein energy wasting has a high incidence and prevalence in this population and that it is associated with poor outcomes it seems logical to screen for it. Early identification allows the possibility to correct some contributing factors and to prevent progression or improve nutritional status. That said, there hasn’t been a well powered randomised controlled trial that demonstrates improved mortality in response to nutritional intervention in this population. Some of the consequences of protein energy wasting include an increased risk of infection, poor wound healing, worsening strength and mobility and consequently depression. We believe that sometimes intervention has the potential to ameliorate some of this. In this section, we shall consider UK national guidance on nutritional screening and look at how it is relevant to renal patients. We shall then elaborate on the techniques that can be used for further assessment. This typically requires input from Dietitians with specialist training / experience of renal populations as well as medical assessment. UK guidance on nutritional screening for hospital patients The Department of Health have previously produced guidelines to reduce the risk of protein energy wasting for hospital in patients. There are 10 principles of good nutritional care to which UK hospitals should adhere1. These include: 1. Nutritional screening on admission and weekly thereafter 2. Individualised nutritional care plans 3. Recognising nutrition as a core part of a hospital’s clinical governance plan 4. Patient involvement 5. Protected mealtimes 6. Ongoing staff education 7. Access to good nutrition for 24 hours every day of the week 8. Performance management of the hospital nutrition policy 9. Safe delivery of nutritional care 10. An MDT approach Subsequently, the NICE quality standard on nutrition support (QS24)2 set out five statements regarding nutritional screening as follows: 1. People in care settings are screened for the risk of malnutrition using a validated screening tool. 2. People who are malnourished or at risk of malnutrition have a management care plan that aims to meet their nutritional requirements. 10 3. All people who are screened for the risk of malnutrition have their screening results and nutrition support goals (if applicable) documented and communicated in writing within and between settings. 4. People managing their own artificial nutrition support and/or their carers are trained to manage their nutrition delivery system and monitor their wellbeing. 5. People receiving nutrition support are offered a review of the indications, route, risks, benefits and goals of nutrition support at planned intervals Given the extra nutritional challenges faced by patients with renal failure, it is particularly important that these guidelines are implemented on renal wards. Many of these principles could be applied to patients on maintenance dialysis programs too. The “Malnutrition Universal Screening Tool” (MUST) developed by the British Association of Parenteral and Enteral Nutrition is recommended by both NICE and the Department of Health for population screening. The risk of undernutrition is calculated from the combination of BMI, percentage unplanned weight loss, presence of acute illness and no nutrient intake for 5 days. Patients can then be stratified as low, medium or high risk. This simple system has the advantage of being easily understood but BMI calculations are not always possible or are compromised in amputees. Rapid changes of weight with water accumulation or removal mean that an extra level of interpretation is needed for renal patients. There are modified screening tools used by some renal dieticians but currently none of these have nationwide recognition. In dialysis populations, a number of other measures that at least partially reflect PEW predict worsened patient survival. These include serum creatinine (Lowrie and Lew 1990)3 (creatinine is dependent on both renal function and muscle mass), serum cholesterol (Lowrie and Lew 1990)3, serum albumin (Lowrie and Lew 1990 3, Blake et al 1993 4), subjective global assessment -which incorporates an assessment of recent nutrient intake (CANUSA 1996)5, body mass index (Kopple et al 1999)6, lean body mass (CANUSA 1996)5, and handgrip strength (Heimburger et al 2000)7. This decrease in survival was originally attributed to undernutrition per se, however there is a strong correlation between inflammation, atherosclerosis and protein energy wasting, (Stenvinkel 2001)8. It is now believed that these processes are synergistic and destructive when they coexist. Low serum albumin is a strong predictor of adverse outcomes. It is often caused by inflammation or salt / water retention, both of which can coexist with protein energy wasting. It is notable that serum albumin levels are often preserved in anorexia nervosa despite marked muscle loss. Although the relationship between albumin and nutritional status is not strong (Jones et al 1997)9, the ISRNM have kept serum albumin as one of the diagnostic criteria for protein energy wasting. They have restated that it is neither necessary nor sufficient to make the diagnosis 10. A low serum albumin should prompt further clinical assessment possibly including a Creactive protein check, a search for evidence of atherosclerosis, an estimate of 24-hour urinary or peritoneal protein loss and determination of circulatory volume status by clinical examination and / or bio-electric impedance depending upon the patient’s circumstances. Bioimpedance analysis is becoming increasingly available and may become a useful way of indirectly measuring changes in muscle mass. This technique could become a 11 useful screening tool in time. We do not believe that the other parameters mentioned above would contribute very much extra to the screening tools we have recommended. We have selected audit measures that should be easy to capture and review using computer databases that are available in most renal units. We also hope to encourage prompt access to specialist dietitians. Further assessment of patients deemed to be at risk of protein energy wasting It is important to differentiate between screening and assessment. Assessment is more detailed and targets patients already considered to be ‘at risk’ of malnutrition, whilst screening targets patients for whom the risk of under-nourishment is unknown. When more detailed assessment is needed, a panel of nutritional measurements should be used because there is no single “gold standard” measure A full nutritional assessment will include a medical history, assessment of dietary intake (which can be done by recall, 3-day food diary and measurement of protein equivalent of nitrogen appearance - all of these have their limitations), anthropometric measures (e.g. mid-arm circumference, triceps skinfold thickness and calculated midarm muscle circumference or handgrip strength) and estimation of dialysis adequacy and of residual renal function. Subjective global assessment (SGA) includes gastrointestinal symptoms (appetite, anorexia, nausea, vomiting, diarrhoea), weight change in the preceding 6 months and last 2 weeks, evidence of functional impairment and a subjective visual assessment of subcutaneous tissue and muscle mass (Enia 1993)8. There are currently eight different versions of SGA described. We had previously recommended it as a useful screening tool. In practice, an SGA is quite time consuming which means it is better used for assessment than screening. There is little evidence to guide the frequency of screening. Monitoring weight on a three monthly basis would allow identification of those that have lost 5% of body weight. In the pre-dialysis period, nutrient intake is likely to be reduced by uraemia, so more frequent screening seems logical. Multi-disciplinary assessment is needed at dialysis commencement to identify those who require dietary advice or supplementation as well as those who need water removal and to balance this with advice on the various dietary restrictions that may be necessary. After 6-8 weeks of dialysis, many patients have symptomatic relief and it may be that the dietary advice needs to change; indeed some restrictions could be relaxed. For stable patients, nutritional changes are likely to be gradual after this. Mechanisms to detect patients that encounter a nutritional challenge between reviews need to be in place. We hope that our audit measures help to develop these if they are not already robust. The importance of multidisciplinary working between doctors, nurses and specialist dieticians in this regard cannot be over-emphasised. References 1. Department of Health. Improving nutritional care: a joint action plan from the Department of Health and Protein energy wasting Summit stakeholders 2007. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitala sset/dh_079932.pdf 12 2. National Institute of Clinical Excellence. Quality Standard 24 (QS24) Nutrition support in adults (2012). http://publications.nice.org.uk/nutritionsupport-in-adults-qs24/list-of-quality-statementsSummary of clinical practice guidelines for protein energy wasting in CKD 3. Lowrie EG, Lew NL. Death risk in hemodialysis patients: the predictive value of commonly measured variables and an evaluation of death rate differences between facilities. Am J Kidney Dis 1990;15:458-482 4. Blake PG, Flowerdew G, Blake RM, Oreopoulos DG. Serum albumin in patients on continuous ambulatory peritoneal dialysis--predictors and correlations with outcomes. Journal of the American Society of Nephrology 1993;3:1501-1507 5. CANUSA study group. Adequacy of dialysis and protein energy wasting in continuous peritoneal dialysis: association with clinical outcomes. Canada-USA (CANUSA) Peritoneal Dialysis Study Group. Journal of the American Society of Nephrology 1996;7:198-207 6. Kopple JD, Zhu X, Lew NL, Lowrie EG. Body weight-for-height relationships predict mortality in maintenance hemodialysis patients. Kidney Int 1999;56(3):1136-1148 7. Heimburger O, Qureshi AR, Blaner WS, Berglund L, Stenvinkel P. Hand-grip muscle strength, lean body mass, and plasma proteins as markers of nutritional status in patients with chronic renal failure close to start of dialysis therapy. American Journal of Kidney Diseases 2000;36:1213-1225 8. Stenvinkel, P (2001) Inflammatory and atherosclerotic interactions in the depleted uremic patient. Blood Purification, 19, 1, 53-61 9. Jones CH, Newstead CG, Will EJ, Smye SW, Davison AM. Assessment of nutritional status in CAPD patients: serum albumin is not a useful measure. Nephrology Dialysis Transplantation 1997;12:1406-1413 10. Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler ATA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevinho-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for proteinenergy wasting in acute and chronic disease. Kidney Int 2008; 73, 391-398. 11. Enia G, Sicuso C, Alati G, Zoccali C. Subjective global assessment of nutrition in dialysis patients. Nephrology Dialysis Transplantation 1993;8:1094-1098 2. Prevention of protein energy wasting in CKD (Guidelines 2.1 – 2.6) Guideline 2.1 – Dose of small solute removal to prevent protein energy wasting We recommend that dialysis dose meets recommended solute clearance index guidelines (e.g. URR or Kt/V) (1C) Guideline 2.2 – Correction of metabolic acidosis and protein energy wasting We recommend that venous bicarbonate concentrations should be maintained above 22 mmol/l (1C) Guideline 2.3 – Minimum daily dietary protein intake We suggest a minimum prescribed protein intake of: o 0.75-1.0 g/kg IBW/day for patients with stage 4-5 CKD not on dialysis o 1.2 g/kg IBW/day for patients treated with dialysis (2B) Guideline 2.4 – Recommended daily energy intake 13 We suggest a prescribed energy intake of o 30-40 kcal/kg IBW/day for all patients depending upon age, gender and physical activity (2B) Guideline 2.5 – Vitamin supplementation in dialysis patients We recommend that haemodialysis patients should be prescribed supplements of water soluble vitamins (1C) Guideline 2.6 – Exercise programs in dialysis patients We recommend that haemodialysis patients should be given the opportunity to participate in regular exercise programmes (1C) Rationale of prevention of protein energy wasting in CKD (2.1-2.6) Many factors predispose to the development of protein energy wasting in patients with CKD. Some, such as changes in appetite, dental problems, vomiting and diarrhoea, may be identified through the patient’s medical history. A decrease in appetite secondary to either uraemia or underdialysis should be confirmed with an assessment of dietary intake, residual renal function and dialysis dose. Dialysis treatment to current Kt/V or URR standards is associated with better nutrient intake than lower doses (Lindsay et al 1989 & Bergstrom et al 1993)1,2. Attempts to increase the small solute clearance further have not demonstrated progressive improvement (Davies et al 2000 & Rocco et al 2004)3,4. Acidosis is an established catabolic factor (Garibotto et al 1994)5 and the bicarbonate concentration of CAPD and HD patients should be maintained within target range to minimise this (Movilli et al 1998)6. Bicarbonate supplementation in the low clearance clinic may also retard the progression of renal failure (de Brito-Ashurst et al 2009)7. The recommended nutrient intakes are similar to those in other protein energy wasting guidelines (KDOQI 2000, Locatelli et al 2002, Cano et al 2006, Ikizler et al 2013)8-11. They are based on small studies of nitrogen balance. It is noted that recommended dietary intakes are set to ensure that 97.5% of a population take in enough protein and energy to maintain their body composition. There is variation in actual nutrient requirement between individuals. This means that some patients will be well maintained with lower nutrient intakes (Slomowitz et al 1989 & Bergstrom et al 1993)12,2. There is quite a wide range of suitable energy intakes. The amount an individual requires depends upon their age, gender, and levels of physical activity Data from the DOPPS suggested that supplementation of water soluble vitamins was associated with significantly lower mortality rates at patient and institution level. Whilst this is survey data, we continue to advise that supplements should be prescribed for haemodialysis patients (Fissell et al 2004)13. 14 Regular exercise will increase lean body mass in healthy individuals. A number of studies of aerobic and progressive resistance training in dialysis patients have shown benefits in terms of cardiovascular performance and either muscle mass or function (see Cheema et al 2005 for a review and & Cheema et al 2007)14,15. The studies are disparate in terms of regime and end-point, but results suggest that patients undergoing regular training improve their strength, exercise tolerance and have a better sense of well-being on Quality of Life scores more often than not. References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Lindsay RM, Spanner E. A hypothesis: the protein catabolic rate is dependent upon the type and amount of treatment in dialysed uraemic patients. American Journal of Kidney Diseases 1989; 13: 382-389 Bergstrom J, Furst P, Alvestrand A, Lindholm B. Protein and energy intake, nitrogen balance and nitrogen losses in patients treated with continuous ambulatory peritoneal dialysis. Kidney International 1993; 44: 1048-1057 Davies SJ, Phillips L, Griffiths AM, Naish PF, Russell GI. Analysis of the effects of increasing delivered dialysis treatment to malnourished peritoneal dialysis patients. Kidney International 2000; 57: 1743-1754 Rocco MV, Dwyer JT, Larive B, Greene T, Cocokram DB, Chumlea WC, Kusek JW, Leung J, Burrowes JD, McLeroy LC, Poole D, Uhlin L. The effect of dialysis dose and membrane flux on nutritional parameters in hemodialysis patients: results of the HEMO study. Kidney International 2004; 65: 2321-2334 Garibotto G, Russo R, Sofia A, Sala MR, Robaudo C, Moscatelli P, Deferrari G, Tizianello A. Skeletal muscle protein synthesis and degradation in patients with chronic renal failure. Kidney Int 1994;45:1432-1439 Movilli E, Zani R, Carli O, Sangalli L, Pola A, Camerini C, Cancarini GC, Scolari F, Feller P, Maiorca R. Correction of metabolic acidosis increases serum albumin concentrations and decreases kinetically evaluated protein intake in haemodialysis patients: a prospective study. Nephrol Dial Transplant 1998;13:1719-1722 De Brito-Ashurst I, Varagunam M, Raftery MJ, Yaqoob MM. Bicarbonate supplementation slows progression of CKD and improves nutritional status. Journal of the American Society of Nephrology 2009; doi: 10.1681/ASN.2008111205 NKF-DOQI clinical practice guidelines for protein energy wasting in chronic renal failure. American Journal of Kidney Diseases 2000;35(S2):S17-S104 (http://www.kidney.org/professionals/kdoqi/pdf/KDOQI2000Protein energy wastingGL.pdf). Locatelli F, Fouque D, Heimburger O, Drüeke TB, Cannata-Andía JB, Hörl WH, Ritz E. Nutritional status in dialysis patients: a European consensus. Nephrol Dial Transplant 2002;17:563-572 Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W, Kuhlmann M, Mann H, Horl WH, ESPEN guidelines on enteral nutrition: adult renal failure. Clin Nutr 2006; 25, 295-310. Ikizler TA, Cano N, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AYM, Wanner C. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int 2013; 84, 1096-1107 Slomowitz LA, Monteon FJ, Grosvenor M, Laidlaw S, Kopple JD. Effect of energy intake on nutritional status in maintenance haemodialysis patients. Kidney International 1989; 35: 704711 Fissell RB, Bragg-Gresham JL, Gillespie BW, Goodkin DA, Bommer J, Saito A, Akiba T, Port FK, Young EW. International variation in vitamin prescription and association with mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). American Journal of Kidney Disease 2004; 44(2):293-299 Cheema BSB, Fiatarone Singh MA. Exercise training in patients receiving maintenance haemodialysis: a systematic review of clinical trials. American Journal of Nephrology 2005; 25: 352-364 Cheema B, Abas H, Smith B, O’Sullivan A, Chan M, Patwardhan A, Kelly J, Gillin A, Pang G, Lloyd B, Fiatarone Singh M. Progressive exercise for anabolism in kidney disease 15 (PEAK): a randomised, controlled trial of resistance training during haemodialysis. Jornal of the American Society of Nephrology 2007; 18: 1594-1601 3. Treatment of established protein energy wasting in CKD (Guidelines 3.1 – 3.6) Guideline 3.1 – General treatment of established protein energy wasting We recommend assessment by a physician to determine and treat possible underlying causes and by a specialist dietician to individualise dietary advice (1D) Guideline 3.2 – Oral nutritional supplements (ONS) in established protein energy wasting We recommend the use of oral nutritional supplements if oral intake is below the levels indicated above and food intake cannot be improved following dietetic intervention (1C) Guideline 3.3 – Enteral feeding in established protein energy wasting We recommend that the use of enteral feeding via a Naso Gastric tube (NGT) / Percutaneous Endoscopic Gastrostomy (PEG) is considered in selected cases if nutrient intake is suboptimal despite oral supplements recognising that there are significant risks and inconvenience associated with these forms of feeding (1C). It is important to consider the patient’s comorbidity, general condition and likely survival prospects before embarking upon invasive treatment such as this. Guideline 3.4 – Parenteral nutritional support in established protein energy wasting We suggest intradialytic parenteral nutrition (IDPN) or intraperitoneal amino acids may be considered for selected cases (2D). Guideline 3.5 – Anabolic agents in established protein energy wasting We recommend that anabolic agents such as androgens, growth hormone or IGF-1. are not indicated in the treatment of protein energy wasting in adults (1D). Guideline 3.6 – Supplementation of micronutrients in established protein energy wasting While deficiencies of fat soluble vitamins, trace elements and carnitine are prevalent in patients with chronic kidney disease current evidence does not support either preventative or therapeutic supplementation. (2C). Rationale of treatment of established protein energy wasting in CKD (3.1-3.6) There is a paucity of well conducted research examining the management of established protein energy wasting in dialysis patients. All reversible factors 16 (including inflammation and occult sepsis) should be identified and corrected. Initiation of dialysis may be required in pre-dialysis patients and dialysis treatment should be optimised. Increased dialysis dose (Ikizler et al 1996), the use of biocompatible membranes (Parker et al 1996;49:551) and provision of ultrapure water (Shiffl et al 2001) are dialysis related factors that have been associated with improved nutritional state1-3, although there are no longitudinal studies in overtly malnourished subjects. It seems sensible to enhance dietary intake with ordinary foods or oral nutritional supplements (ONS) (Steinvinkel 2005)4. There have been recent publications used to support the prescription of ONS treatment (Lacson et al 2012, Cheu et al 2012)5,6. These studies are observational in nature and suffer from the consequent confounding of this design. They imply that patients engaging with dietetic support programs do better than those that don’t. One study looked at use of supervised oral supplements during dialysis treatment. This seems like an attractive idea as concordance would be clear and fluid removal could be optimised. We have previously recommended enteral feeding by nasogastric tube or percutaneous endoscopic gastrostomy for those patients that struggle to take oral supplements. Our enthusiasm for this approach has diminished. The evidence to support enteral tube feeding is limited to a few small observational studies. Improvements in body weight, mid-arm circumference and serum albumin were reported by Sayce7 whilst Holley8 reported only an improvement in serum albumin. Adora et al (2014)9 reviewed 181,196 PEG insertion procedures in the US and found that renal patients had a 1.6-fold increased risk of mortality. Having PEW increased mortality risk to 5.25-fold when compared to patients with head and neck disease preventing oral intake. PEG feeding should be considered on an individual basis. It may be appropriate if a patient has an unsafe swallow and they wish to continue with active treatment. Intradialytic parenteral nutrition (IDPN) (Foulks 1999)10 and intraperitoneal amino acid supplementation (in PD) (Jones et al 1998)11 can be considered, although evidence of benefit is limited (Cano 2007)12. The FINE study by Cano et al13 compared ONS to ONS and IDPN in a randomised control trial. Survival rates did not differ between the two groups. We have seen some patients improve when receiving IDPN and we continue to offer it to people that typically have little systemic inflammation and a poor oral nutrient intake. Pharmacological therapies include subcutaneous growth hormone (Johannsson et al 1999), insulin-like growth factor (Fouque et al 2000) and oral androgens (Barton et al 2002)14-16. Again evidence of benefit is limited. All of these interventions are expensive and are associated with potentially serious side effects. As such, we do not recommend their use. References 1. Ikizler TA, Greene JH, Wingard RL, Parker RA, Hakim RM. Spontaneous dietary protein intake during progression of chronic renal failure. J Am Soc Nephrol 1995;6:1386-1391 17 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Parker TF 3rd, Wingard RL, Husni L, Ikizler TA, Parker RA, Hakim RM. Effect of the membrane biocompatibility on nutritional parameters in chronic hemodialysis patients. Kidney Int 1996;49:551-556 Schiffl H, Lang SM, Stratakis D, Fisher R. Effects of ultrapure dialysis fluid on nutritional status and inflammatory markers. Nephrol Dial Transplant 2001;16:1863-1869 Stenvinkel, P (2001) Inflammatory and atherosclerotic interactions in the depleted uremic patient. Blood Purification, 19, 1, 53-61 Lacson E, Wang W, Zebrowski B, et al. Outcomes associated with intradialytic oral nutritional supplements in patients undergoing maintenance haemodialysis: a quality improvement report. Am J Kid Dis 2012; 60:591-600. Cheu C, Pearson J, Dahlerus C, et al. Association between oral nutritional supplementation and clinical outcomes among patients with ESRD. Clin J Am Soc Nephrol 2012; 8: 100-107 Sayce H, Rowe P, McGonogle R. Percutaneous Endoscopic Gastrostomy Feeding in Haemodialysis Out-patients. J. Human Nutr Diet 2000; 13: 333-341 Holley J, Kirk J. Enteral Tube Feeding in a Cohort of Chronic Haemodialysis Patients. J Ren Nutr 2002; 12: 177-182 Arora G, Rockey D, Gupta S. High In-hospital mortality after percutaneous endoscopic gastrostomy: results of a nationwide population-based study. Clinical gastroenterology and hepatology 2013; 11: 1437-1444 Foulks CJ. An evidence-based evaluation of intradialytic parenteral protein energy wasting. Am J Kidney Dis 1999;33:186-192 Jones M, Hagen T, Boyle CA, Vonesh E, Hamburger R, Charytan C, Sandroni S, Bernard D, Piraino B, Schreiber M, Gehr T, Fein P, Friedlander M, Burkart J, Ross D, Zimmerman S, Swartz R, Knight T, Kraus A, McDonald L, Hartnett M, Weaver M, Martis L, Moran, J. Treatment of malprotein energy wasting with 1.1% amino acid peritoneal dialysis solution: results of a multicenter outpatient study. American Journal of Kidney Diseases 1998;32:761769 Cano NJ, Fouque D, Roth H et al. Intradialytic parenteral protein energy wasting does not improve survival in malnourished hemodialysis pateints: a 2-year multicenter, prospective, randomized study. Journal of the American Society of Nephrology 2007; 18: 2583–2591 Cano NJ, Fouque D, Roth H, et al. Intradialytic parenteral nutrition does not improve survival in malnourished haemodialysis patients: a 2 year multi-centre prospective, randomized study. J Am Soc Nephrol 2007; 18: 2583-2591 Johannsson G, Bengtsson BA, Ahlmen J. Double-blind, placebo-controlled study of growth hormone treatment in elderly patients undergoing chronic hemodialysis: anabolic effect and functional improvement. Am J Kidney Dis 1999;33:709-717 Fouque D, Peng SC, Shamir E, Kopple JD. Recombinant human insulin-like growth factor-1 induces an anabolic response in malnourished CAPD patients. Kidney Int 2000;57:646-654 Barton Pai A, Chretien C, Lau AH. The effects of nandrolone decanoate on protein energy wastingal parameters in hemodialysis patients. Clin Nephrol 2002;58:38-46 1. Nutritional management of in-patients with stage IV-V CKD Guideline 4.1 - Patients with acute kidney injury We support the comments made about nutritional management of AKI in the Renal Association AKI guideline document. Guideline 4.2 - CKD patients with intercurrent illness We recommend that this patient group is screened on admission to hospital and a nutritional care plan constructed that takes account of their risk. Re-screening should be carried out at weekly intervals. Early referral to specialist dietitian is important in this group. Guideline 4.3 - Refeeding syndrome 18 We recommend that a patient is assessed in order to establish the risk of re-feeding syndrome. A patient will be at high risk of re-feeding syndrome if: Any one of the following: BMI<16kg/m2 Weight loss of >15% over 3-6/12 Poor intake for 10 days Low Potassium, Phosphate or Magnesium electrolytes Any two of the following: BMI<18.5kg/m2 Weight loss >10% over 3-6/12 Poor intake for 5 days A history of alcohol abuse or the use of insulin, chemotherapy, antacids or diuretics At extremely high risk of refeeding syndrome if: BMI <14kg/m2 Very little or no nutrition for >15 days If the patient is at risk of re-feeding syndrome we recommend that vitamin B (eg Vitamin B co strong 2 tablets tds) and thiamine supplements (100mg tds) should be prescribed for 10 days. We recommend that potassium, phosphate and magnesium levels should be monitored daily when nutritional support commences. These should be supplemented according to BAPEN guidelines (explained further below). Rationale of Nutritional management of in-patients with stage IV-V CKD (4.14.3) When admitted to hospital acutely unwell, alterations to metabolism of nutrients, fluid balance, acid-base balance and treatment can impact on patients nutritional needs. For this reason patients with CKD should be treated as a patient with acute kidney injury (AKI) during periods of acute inter-current illness1. AKI itself does not impose any additional stress to the patient, it is the cause of the AKI or treatment being received that will dictate the nutritional prescription. Energy requirements should ideally be calculated using indirect calorimetry, this is however rarely used in practice. Energy requirements should therefore be estimated using BMR calculations with additions for activity and stress factors or calories/kg/day. If using BMR calculation, such as Henry, Harris-Benedict or Schofield, stress factors of more than 30% are not thought to be required even in multi-organ failure as overfeeding has been associated with negative outcomes such as hyperglycaemia and hyperlipidaemia1,2. Alternatively energy requirements can be calculated using 20-35kcal/kg/day, aiming for the lower end during the early critical 19 illness phase on the intensive care unit to the upper end when the patient is more stable1,2. Protein requirements range from 0.75-1.7g protein/kg BW dependent upon the cause of the acute illness (catabolic, non-catabolic) and the treatment being received. Aiming from 0.75-1.0g/kg for the non-catabolic patient not requiring dialysis to 1.7g/kg for the hypercatabolic patient receiving CRRT (see figure 1.). The exact protein requirements for those receiving continuous renal replacement therapy remain unclear but doses of between 1.5-1.7 g/kg BW/24 hours are usually suggested. Intermittent haemodialysis protein requirements should be prescribed at 1.2-1.5g/kg BW depending on catabolic state. Figure 1 Protein requirements in Acute Kidney Injury Individuals with established CKD on admission to hospital may already have dietary restrictions imposed including potassium, phosphate, salt or fluid. During acute illness reduced intakes are common and adhering to dietary restrictions can have a negative impact on this. Patients should be counselled on dietary allowances, relaxing restrictions where possible in order to help them meet their nutritional requirements. The UKs largest hospital study found 29% of patients to be at risk of malnutrition on hospital admission 3. Within the renal inpatient setting prevalence of malnutrition has been estimated to be about 43-52%4,5,6. Nutritional status is reported to worsen in two thirds of patients during their hospital stay3. The National Institute of Clinical Excellence (NICE) Guidelines on Nutrition support in adults; Oral nutrition support, enteral tube feeding and parenteral nutrition (2006) 7 advise that in-patients should be screened for risk of malnutrition on admission and at weekly intervals thereafter. Identification of at risk patients can allow for prompt referral to the dietitian for further assessment, division and implementation of a care plan and review of outcomes. 20 All individuals should have their risk of re-feeding syndrome assessed. The criteria we have listed for this risk assessment are consistent with the NICE guidance Nutrition support in adults7 and the BAPEN decision tree on refeeding syndrome (2012)8 Refeeding syndrome can occur in malnourished individuals, in those that have had minimal nutrition for a period of time or in those with a history of excess alcohol, in those on drugs such as insulin, chemotherapy, antacids and diuretics. Refeeding problems include life threatening acute micronutrient deficiencies, fluid and electrolyte imbalances and disturbances of metabolic processes which result from over-rapid or unbalanced nutrition support7 During periods of starvation ketone bodies and fatty acids replace glucose as its major energy source. Several intracellular minerals become severely depleted, including potassium, phosphate and magnesium, although serum levels may be normal. On refeeding, there is a release of insulin to deal with the carbohydrate intake and decreased glucagon secretion. Potassium, magnesium and glucose shift into the cells and hypophosphataemia results due to increased phosphorylation of glucose. Sodium and water move out into the extracellular volume, thus leading to reduced serum levels and potential fluid overload / oedema9. Thiamine is an essential coenzyme for carbohydrate metabolism, if depleted due to inadequate intakes/starvation this can lead to Wernicke’s encephalopathy or Korsakoff’s syndrome, thiamine replacement is therefore essential9. Biochemical changes that can occur as a result of refeeding include hypophosphataemia, hypokalaemia, hypomagnesaemia and occasionally hypocalcaemia. Hyperglycaemia may also occur secondary to inadequate circulating insulin. Acute clinical conditions can result from this including cardiac failure, pulmonary oedema and dysrhythmia, acute circulatory fluid overload or fluid depletion and deterioration in neurological state and confusion. Patients identified as being at risk of refeeding syndrome should be referred to the dietitians. Ensure adequate thiamine and B vitamins before and during the first 10 days of feeding: consider IV vitamin B preparation (eg pabrinex), or high dose oral thiamine (200-300mg/day) and Vitamin B Co strong 1-2 tablets/day8. Assistance should be sought from the dietitian and pharmacist. In patient with CKD the prescription of a balanced multivitamin and trace element supplement should be considered with caution due to the risk of vitamin A toxicity10. The ideal route of nutritional support should be agreed and commencement of nutritional intake based on 5-10kcal/kg dependent on the patients refeeding risk7,8. Serum urea, sodium, potassium, phosphate, magnesium and calcium should be monitored daily and blood sugars checked daily. For more information on re-feeding syndrome see: http://www.bapen.org.uk/pdfs/decision-trees/refeeding-syndrome.pdf References 21 1. Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W. ESPEN Guidelines on Enteral Nutrition: Adult Renal Failure. Clinical Nutrition 2006; 25, 295–310 2. KDIGO Clinical Practice Guidelines for Acute Kidney Injury. Kidney International Supplements (2012) 2, 1; doi:10.1038/kisup.2012.1 3. British Association for Parenteral and Enteral Nutrition (2014). Nutrition screening surveys in hospitals in the UK, 2007-2011. A report based on the amalgamated data from the four nutrition screening week surveys undertaken by BAPEN in 2007, 2008, 2010 and 2011. Edited by Elia, M., & Russell, C. Retrieved from http://www.bapen.org.uk/pdfs/nsw/bapennsw-uk.pdf 4. Fisher, K., Paxton, R., Jackson, H., Noble, S., Thomsett, K., Reynolds, S., Hart, K. & Engel, B. (2011). Comparison of screening tools in patients undergoing haemodialysis. Journal of Human Nutrition and Dietetics, 24, 282-283. 5. Bourke, N., Mafrici, B., Livesey, L., Peacock, V., & Roe, S. (2010). The use of Malnutrition Universal Screening Tool (MUST) on renal wards compared to a ward based renal dietitian: Which is better? Journal of Human Nutrition, 1, 53. 6. Fiaccadori, E., Lombardi, S., Rotelli, C.F., Tortorella, G., Borghetti, A. (1999) Prevalence and clinical outcome associated with pre-existing malnutrition in acute renal failure: prospective cohort study. J Am Soc Nephrol. 1999; 10(3):581-93 7. NICE Guidance. Nutrition support in adults: oral nutrition support, enteral tube feeding and parenteral nutrition. 2006. 8. http://www.bapen.org.uk/pdfs/decision-trees/refeeding-syndrome.pdf 9. Stanga Z, Brunne A, Leuenberger M, Grimble RF, Shenkin A, Allison SP,Lobo DN Nutrition in clinical practice - the refeeding syndrome: illustrative cases and guidelines for prevention and treatment. European Journal of Clinical Nutrition 2008; 62, 687–694 10. Makoff R. Vitamin supplementation in patients with renal diseases. Dial Transplant 1992; 21: 18-36. . 22