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Transcript
6. BRIEF RESUME OF THE INTENDED WORK
6.1 Need for Study
In modern day medical practice, intravenous catheters form an integral part of Intensive Care
Units. Critically ill patients are frequently monitored by Central Venous Catheters (CVC), to
assess central circulation, for infusion, nutritional support, hemodynamic monitoring,
haemodialysis, plasmapheresis and apheresis.1
Catheter Related Blood Stream Infection (CRBSI) is an infection of recent times.2
Both infectious and non-infectious complications have been reported following Central
Venous Catheterisation. Of all the “Device related nosocomial infections”, CRBSI forms a
major part.3
Healthcare associated septicaemia, are most commonly caused by CRBSI, making it the most
expensive and lethal complication of Central Venous Catheterisation.4
ICUs occupy approximately 10% of the hospital bed capacity and are responsible for 25% of
all nosocomial infections.5
Definitive diagnosis of CRBSI can be made by supplementing clinical signs and symptoms
with Quantitative Cultures of CVC and simultaneous peripheral blood culture.
Very few studies on the proportion of CRBSI have been conducted in India.2
Hence, procuring this data would be of significance in realising the burden of the condition,
applying preventable measures and for providing insight for correct antibiotic usage based on
sensitivity pattern at our Healthcare Setup.1
2
6.2 Review of Literature
CRBSI is defined as bacteraemia or fungemia in a patient who has an intravascular device
and a positive result of culture of blood samples obtained from the peripheral vein, clinical
manifestations of infection (fever, chills and/or hypotension) and no apparent source of
bloodstream infection with the exception of the catheter.6
11% of Hospital Acquired Infections are due to Central Venous Catheter Related BSI.7
Incidence of catheter related infections from various studies ranges between 2.7 to 60%.2
Patil et.al. undertook a study on CRBSI among ICU patients, and reported the overall
incidence as 27.77& or 47.31 per thousand catheter days. Microbes isolated were Coagulase
Negative Staphylococcus aureus (CoNS) (65%); Staphylococcus aureus being the
commonest (45%). All Gram Positive Cocci exhibited resistance to Penicillin, while Gram
Negative organisms were resistant to multiple drugs.2
A study by Gahlot et.al., demonstrated CLABSI rate of 12.5% or 10 per 1000 catheter days,
with two-thirds of the organisms being Gram Positive Cocci (71%) and 22% being NonFermenters and 7% Candida spp.4
Bacterial colonisation in the catheter may be due to many risk-factors like, poor personal
hygiene, occlusive dressing, moisture around exit-site, nasal carriage of Staph. aureus
infection.4
A prospective and observational study conducted over 3years by Lorrente et.al. concluded
CRBSI incidence of 2.79 per 1000 catheter days.8
3
An alarming increase in the rate of anti-microbial resistant organisms like, Methicillin
Resistant Staph. aureus (MRSA), Multi Drug Resistant Gram Negative Bacilli and
Fluconazole Resistant Candida, have been observed over the past two decades.7
Coagulase Negative Staph.aureus (31%), Staph.aureus (20%), Enterococci (9%), E.coli
(6%), Klebsiella spp. (5%) and Candida (9%) have been found to be the most commonly
isolated organisms in CLABSI.7
4
6.3 Objectives
1) To determine the proportion of Central Venous Catheter Related Blood Stream Infection
among patients admitted in ICU.
2) To isolate and characterise the causative agents (bacterial).
7. MATERIALS AND METHODS
7.1 Source of Study:
Central Venous Catheter tips and simultaneous peripheral blood samples from patients with
CVC, admitted in ICU at M.S. Ramaiah Hospitals.
Duration of Data Collection:
January 2014 to December 2014 (12 months)
Inclusion Criteria:
1) All patients admitted in ICU with CVC.
Exclusion Criteria:
1) Patients whose CVC was put outside M.S. Ramaiah Hospitals.
5
7.2 Methods of Data Collection:
Study Design:
Prospective Study
Sample Size:
From the literature study “Central Venous Catheter Related Blood Stream Infection in the
Intensive Care Unit” by Patil et.al., conducted in 2004, it has been observed that the
incidence of CVC related BSI is 27.77%. In the present study, expecting similar results, with
90% Confidence and 20% Relative Precision, we require a minimum sample of 175 study
subjects.
Statistical Methods:
Descriptive Statistics of Proportion of CRBSI would be analysed and presented in terms of
percentage and its 90% Confidence Interval would be determined.
Chi-Square Test would be used to find the difference of infection rates between duration of
catheterisation, age and between different co-morbidities.
6
Study Method:
CVC tips and Peripheral Blood Samples from 175 patients would be collected.
Catheter Tips will be processed bya) Extra-luminal Maki’s Roll-over Plate Method.1
b) Endo-luminal Catheter Flush Culture.
Blood samples will be analysed using the BacT ALERT System (bioMeriux, Hazelwood,
Missouri, USA).1
Positive blood cultures will be furthur sub-cultured and organisms will be identified by
Standard Biochemical Tests.9
Antibiotic Susceptibility Patterns will be performed by Kirby-Bauer Disk Diffusion Method
as recommended by Clinical Laboratory Standards Institute (CLSI) – 2013.1
7.3 Does the study require any investigations or interventions to be conducted on
patients or animals?
No.
7.4 Has Ethical Clearance been obtained from institution in case of 7.3?
Yes. (Copy enclosed.)
7
8. LIST OF REFERENCES
1. Parameshwaran. Ramanathan, Sherchan. Jatan B., Varma D. Muralidhar, Mukhopadhyay.
Chiranjay, Vidyasagar. Sudha, “Intravsacular Catheter-related infections in an Indian Tertiary
care hospital”; J Infect Dev Ctries 2011; 5(6):452-458.
2. Patil. Harsha V., Patil, Virendra C., Ramteerthkar. M.N., Kulkarni, R.D., “Central venous
catheter-related bloodstream infections in the intensive care unit”; Indian Journal of Critical
Care Medicine October-December 2011; 15(4): 213-223.
3. Chopdekar. K, Chande.C, Chavan.S, Veer.P, Vishwakarma.K, Joshi.A, “Central venous
catheter-related blood steam infection rate in critical care units in a tertiary care, teaching
hospital in Mumbai”; Indian Journal of Medical Microbiology, (2011) 29(2): 169-71.
4. Gahlot.Rupam, Nigam.Chaitnya, Kumar.Vikas, Gupta.Munesh, “Catheter Related Blood
Stream Infections in ICU: A Study from North India”; International Journal of infection
Control 2013, 9(2):
5. Banda. Venkata Ramana, Chaudhary. Abhijit, “Device associated nosocomial infections
and patterns of antimicrobial resistance at a tertiary care hospital”; Journal of Dr. NTR
University of Health Sciences 2012; 1(2): 86-89.
6. Mathur.Purva, “Catheter-Related Bloodstream infections”; Hospital Acquired Infections,
Prevention and Control, First Edition, Lippincott, Williams and Wilkins, 2010: 338-373.
7. Abad.Cybele L., Safdar. Nasia, “Catheter-related Bloodstream Infections”; Infectious
Disease Special Edition 2011: 84-98.
8. Lorente.Leonardo, Henry.Christophe, Martin.Maria.M., Jimenez.Alejandro, Mora.Maria
L., “Central venous catheter-related infection in a prospective and observational study of
2,595 catheters”; Critical Care 2005, Vol 9 No 6: 631-635.
8
9. Collee JG, Miles RS, Watta B, “Tests for the identification of bacteria”, Mackie &
McCartney, Practical Medical Microbiology, 14th Edition; Churchill Livingstone, 2006:
131-142.
9