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Policy Name: Continuous Renal Replacement Therapy via the Prismaflex® 5.1 System Procedure Effective Date: 03/29/13 Policy Primary: Status: Published Final Approval: Approved by: DUH Critical Care Standards Committee Date: Glossary: Term: Definition: Definitions: The Prismaflex® 5.1 System is a fully integrated system for automated CRRT and continuous fluid management. The Prismaflex® 5.1 System provides four therapy options: Slow Continuous Ultrafiltration (SCUF) provides fluid removal by ultrafiltration only. No replacement or dialysis fluid is used. The maximum patient fluid removal rate in SCUF is 2000 ml/hr. Continuous Veno-Venous Hemofiltration (CVVH) is a process of hemofiltration which is designed primarily to remove fluid, but also removes some solutes by convection as the patient's blood moves across a semi-permeable membrane. Convection is the process which uses the force of fluid to remove solutes and is optimized by infusing replacement fluid. It offers high volume ultrafiltration using replacement fluid which can be given pre-filter (pre-dilution) and/or post-filter (post-dilution). The maximum patient fluid volume removal in CVVH is 2000 ml/hr. Continuous Veno-Venous Hemodialysis (CVVHD) provides solute removal by diffusion. Solutes pass from the patient's blood across the semi- permeable membrane into the dialysate flowing through the fluid compartment of the filter. Diffusion is the process by which ions move from an area of higher to lower concentration. The concentration of solutes is higher in the blood than it is in the dialysate. This results in the solutes moving from the blood to the dialysate. Maximum patient fluid removal is 2000 ml/hr. Continuous Veno-Venous Hemodiafiltration with Fluid Replacement (CVVHDF) is the same process as noted in #2 and #3 above utilizing both ultrafiltration, convection and diffusion. Definitions 1. Pressures o o o o Access - coming from the patient, always a negative number Filter- reflects amount of difficulty for PRISMAFLEX system to get blood into the filter, as this number increases there may be increased incidence of clotting Effluent- amount of pressure on the kidney membrane, increases as opportunity to clot increases Return - amount of pressure to return blood to the patient Intellectual Property of Duke Health. All Rights Reserved. Page 1 of 8 o Transmembrane Pressure- amount of pressure within the filter NOTE: These pressures should be monitored on a routine basis for trending. As the trend pressure increases, the opportunity for clotting increases. It is preferred that the system be changed prior to a clotting event so the patient experiences minimal to no blood loss (cannot return blood if the kidney clots). 2. Filtration Fraction – A Filtration Fraction > 25%, enhances the "protein cake" on the surface of the inner filter membrane, increasing pore clogging and clotting. This will lead to the need for early replacement of the hemofilter set. To decrease the Filtration Fraction percentage, prescribed fluid delivery strategies may need to be initiated such as a mix of pre- and post-dilution. NOTE: For accurate Filtration Fraction percentage monitoring, the patient’s hematocrit should be updated once a day. Indications: Patients experiencing acute renal failure who require fluid removal,control of azotemia in hyper-catabolic states and have electrolyte imbalances. A nephrology consult is necessary prior to establishing the need for treatment. This therapy is not recommended for "No Heparin" treatment unless the patient is systemically heparinized or has a coagulopathy that prevents normal clotting. Contraindications: Any patient receiving ace – inhibitors has a high incidence of anaphylaxis. The Prismaflex® machine does NOT have a battery back up; therefore, the therapy will need to be discontinued to travel for any diagnostic testing or procedure. RESPONSIBILITIES Nephrology team (Attendings, Fellows, Residents) A consult will include: Type or mode of therapy to be used Completing the dialysis order set Baseline and ongoing lab studies, with parameters Intellectual Property of Duke Health. All Rights Reserved. Page 2 of 8 Ultrafiltration rate Composition of replacement fluid and rate (pre and/or post replacement) Composition of dialysate fluid and rate Pre-blood pump fluid and rate Blood pump speed Net fluid balance Anticoagulation circuit orders and parameters Vascular access in conjunction with the ICU team. Hemodialysis or other competent staff responsibilities: Verifies physician orders Initiates system setup Sets up the dialysis machine, delivers to ICU and initiates therapy Changes (resets) circuit every 72 hours or as indicated Evaluates patient's response to therapy and documents daily on progress note Serves as a consultant and resource to the ICU staff. ICU staff responsibilities: Verifies physician orders Assists with vascular access placement Patient assessment Documents q 2 hrs net fluid removal and pressure values on flowsheet or electronic health record Maintains the Prismaflex system *Discontinues system and return blood as ordered – See "NOTE" below. NOTE: If the machine has alarmed and the screen states "FILTER CLOTTED", DO NOT RETURN the blood. If the machine had given the advisory alarm "FILTER IS CLOTTING", return blood and notify Hemodialysis staff. If a clot is noted in the Deaeration Chamber, the blood in the circuit can still be returned because the clot will not go through the tubing. If the clot did go to the tubing, the pressure in the system would be too high and the machine would say "RETURN EXTREMELY POSITIVE" and the machine would not allow the blood to be returned. Assesses circuit integrity for leaks, loose connections, clots *Changes anticoagulant every 24 hours and prn *Notify pharmacy when additional potassium or other additive bags or syringes are needed Provides and documents patient/family education. Pharmacy will prepare and provide WITH SPECIAL LABELING per order: *Anticoagulant Syringe (must be in a 20ml leur-lock syringe) or infusion bag *Potassium or other additives for the system. Intellectual Property of Duke Health. All Rights Reserved. Page 3 of 8 Level: Interdependent - asterisked [*] items require an order from a health care practitioner licensed to prescribe medical therapy. Personnel: CRRT procedures will be performed by RNs and LPNs that have demonstrated competency. CRRT is available in Critical Care Units only Competencies/Skills: Required Resources: Provided by the Renal Team Prismaflex System 5.1 Unit Prismaflex Set (M100 or M60) Effluent bag 20 ml syringe filled with Normal Saline Therapy: Effluent bag replacements Replacement syringes (if medication ordered) Electrolyte additives (if ordered) Replacement solutions Adapter, Spike Accessory SAP# 344839 Policy Statement: Purpose:To outline the responsibilities of the RN, and Nephrology Team in the care of the adult and pediatric patient receiving continuous renal replacement therapy (CRRT), set-up, maintenance and discontinuation of the Prismaflex® 5.1 System. Content: A. Setup: 1. Reinforce physician's explanation and provide reassurance to the patient during the procedure. 2. The Renal Fellow or Dialysis nurse will set up the Prismaflex control unit, prime the tubing, connect to the patient, and set the initial flow rates, anticoagulant therapy dosing, and alarms. 3. The Renal fellow or Dialysis nurse will have 24 hour responsibility for all Prismaflex set changes. 4. The Renal attending/fellow is responsible for writing orders to include: Intellectual Property of Duke Health. All Rights Reserved. Page 4 of 8 a. b. c. d. e. f. Mode of therapy Goal for fluid therapy Flow rates Anticoagulant doses, parameters, and routine aPTTs Monitoring labs Response to unplanned emergent situations, i.e. filter membrane rupture, anaphylaxis g. Emergency beeper number for 24-hour on-call renal fellow. B. Maintenance of System: 1. Verify that all connections are secure to the patient to prevent leakage, blood loss, air embolism and clots. CLAMP any lines that are not in use or have a flow rate of ZERO. 2. Verify that Prismaflex tubing is inserted into the air detector. 3. Record date and time CRRT is initiated. 4. After initiation of therapy, monitor net fluid removal and pressures values and flow settings. Document pressures at least q 2 hrs and flow settings q shift and with any changes.NOTE: A Filtration Fraction of Greater than 25% indicates that the blood may become too hemoconcentrated as it moves through the hemofilter and require early changing of the hemofilter set. 5. Monitor the blood leak detector. The machine will alarm and stop when the color changes from amber to pink. 6. Alarm conditions should be promptly addressed to prevent hemostasis, clotting of the filter, and patient complications. 7. *If Citrate used for anticoagulation, a calcium drip must be infused through a central line, not the access port of the hemodialysis catheter. The circuit will be monitored by drawing ionized calcium from the post-filter port (blue). 8. *Coagulation studies will be monitored as ordered when heparin is used for system anticoagulation. 9. *Machine aPTTs will be obtained from the post-filter port (blue). 10. Change dialysis solution bags when prompted to do so by Prismaflex machine's calculation time or prn by using change bag feature on machine. 11. Empty effluent bag when full and alarm sounds (recalibrates simultaneously at change). 12. Confirm that circuit is changed at least q 72 hrs or if indicated. 13. Use a 22-gauge needle to obtain blood or fluid samples (from blue port), or remove air trapped in the Prismaflex set. C. Patient Assessment: 1. Circulatory assessment of the extremity every 2 hours if femoral vein is used for catheter insertion site. 2. Obtain baseline assessment data, VS, I & O, daily weight*. 3. After initiation of therapy, monitor hemodynamic, respiratory and neurologic status every two hours. 4. Monitor for signs of acute allergic reaction. 5. Monitor acid/base balance and electrolytes. 6. Assess fluid status for signs of dehydration. 7. Monitor for hypothermia – use warming device on Prismaflex or another external device (warm air unit or Bair Hugger®). 8. *Monitor patient ionized calcium if citrate is being used for system (machine) anticoagulation. Intellectual Property of Duke Health. All Rights Reserved. Page 5 of 8 D. Changing Anticoagulant Dose: 1. *Monitor frequency of aPTT or ionized calcium and titration as ordered. 2. Change anticoagulant every 24 hours and prn. NOTE: Advisory Alarm: "Syringe Almost Empty" indicates the syringe will be empty in 5 minutes. E. Adding Potassium (KCI) to Dialysate: 1. Obtain correct dose minibag from Omnicell. 2. Perform hand hygiene. 3. Using secondary IV tubing set, spike the potassium (KCI) minibag. 4. Break BLUE pin as instructed on bag of dialysate. 5. Attach secondary tubing to BLUE port on dialysate bag. 6. Squeeze contents of potassium (KCI) minibag into dialysate bag. 7. Remove secondary tubing and minibag from dialysiate bag. 8. Label dialysate bag with medication and dose added, date, time and initials. F. Discontinue Treatment: 1. To terminate treatment, press "End Treatment." 2. *Press "Return Blood" soft key only if blood is to be returned to the patient at the end of treatment. 3. *Enter desired return blood rate (10 – 100 ml/min, physician order). 4. Hang 250 - 500ml NS on upper left side hook. 5. Clamp red access line and disconnect line from patient. 6. Connect red access line to the "accessory spike" and spike into the saline flush bag and unclamp access line. 7. Hold down "Start Return" key. (Return desired amount of blood, approximately 100 ml of saline is required to flush line.) 8. Press "Continue" to disconnect patient. 9. Clamp all lines in set. 10. Disconnect return line from the patient. 11. Disconnect anti-coagulant line from anticoagulant syringe. 12. Press "Unload" key to unload set. The control panel automatically unloads lines from raceways. 13. *Attach continuous flush system to both ports of the hemodialysis catheter. (Refer to: Permcath and Vascath Access Protocol) unless otherwise ordered. (*PICU instill heparin 1000units/ml, priming volume of each lumen as printed on each catheter port). G. Troubleshooting: 1. For an alarm secondary to an occlusion, reposition the patient, check patency of access, and/or switch lines to see if this relieves the occlusion. 2. After alarm has been "corrected", continue, if alarm reoccurs, then original problem has not been corrected. Notify HD nurse. 3. The filter and effluent pressures increase as clotting potential increases. 4. Any blood products or medications should be administered via a non-Prismaflex line with the exception of citrate. H. Documentation: 1. Document the following: a. Prismaflex pressures at least q 2hrs and flow settings q shift and with any changes. b. Access site I. Critical Events – RN to Notify Provider Immediately Intellectual Property of Duke Health. All Rights Reserved. Page 6 of 8 1. Discontinue CRRT immediately if profuse bleeding occurs. 2. If tubing disconnection occurs, clamp blood tubing and vascular access immediately. 3. If using Citrate for anticoagulation and calcium drip stops, immediately STOP Citrate infusion by going to FLOW RATE screen and change pre-blood pump (PBP) rate to ZERO until calcium is infusing. NOTE: If citrate therapy is stopped, immediately STOP calcium drip. 4. If air embolism is suspected, provide emergency interventions: a. Discontinue CRRT system and DO NOT RETURN BLOOD. b. Position patient on left side with head lower than chest (Trendelenburg) c. Administer oxygen as ordered d. Assess for changes in vital signs e. Notify provider. Reportable Conditions – RN to Notify Provider Immediately 1. 2. 3. 4. 5. Clotted circuit, line leakage, rupture of filter membrane Abnormal VS or lab results Signs of bleeding Signs of anaphylaxis Significant changes in assessment, i.e. AMS (altered mental status), dysrhythmias or ectopy, increased SOB, drop in SBP > 20 mmHG in ADULTS and > 10 mmHG in PEDIATRICS 6. Increased trending of filter or effluent pressures. Notify dialysis nurse ASAP. 7. Signs of dehydration Resources: Renal Team (0700-2100) 681-7880. Page 970-7701 or 970-8461 between 2100-0700 REFERENCES Citations: ANNA standards of clinical practice for Continuous Renal Replacement Therapy, 2000 Augustine JJ, Sandy D, Seifert TH, Paganini EP. (2004). A randomized controlled trial comparing intermittent with continuous dialysis in patients with ARF. American Journal of Kidney Diseases. 44(6): 1000-7. Small KR, McMullen M. (2005). When clear becomes cloudy: a review of acute tubular necrosis, a form of renal failure. American Journal of Nursing. 105(1): Critical Care Extra: 72AA-BB, 72EE, 72GG. Prismaflex® 5.1 Operator’s Manual, Gambro Dasco S.p.A. 2005 Policies: Authoritative Source: Intellectual Property of Duke Health. All Rights Reserved. Page 7 of 8 Additional References: Attachment Names: Company: Entities: DUH Intellectual Property of Duke Health. All Rights Reserved. Page 8 of 8