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© SICS EBM Group 2004
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Oligon-impregnated central venous catheters to prevent catheter-related bloodstream infection
Lead author's name & email: Marco Ranucci, cardioanestesia@virgilio.it
Three-part Clinical Question: Do oligon-impregnated central venous catheters prevent catheter-related bloodstream infection in medical and surgical patients requiring central venous catheterisation?
Search Terms: Medline and Pubmed; search terms: intensive care, critical care, central venous catheters, infection, prevention, controlled trial, systematic review, meta-analysis. Back-chaining of relevant papers.
The Study: Multi-centre, prospective, randomised controlled trial. Patients were randomly allocated to the experimental or control group according to a computer-generated randomisation code. The authors do not stipulate if there was any blinding of operator, remover of catheter or microbiologist.
The Study Patients: All patients over 18 years of age who required central venous catheter (CVC) insertion, likely to require an indwelling period of more than or equal to 3 days, for either medical or surgical pathologies. They excluded pregnant women, patients with a diagnosis of systemic infection at the time of insertion, and patients with a history of allergy to any of the components of the study or control catheters.
Definitions: Catheter colonization: growth of more than or equal to 15 colony-forming units in culture of catheter segments by the roll-plate method, or more than or equal to 1000 colony-forming units for the sonication method. Catheter-related bloodstream infection: isolation of the same organism from the colonised catheter and from the peripheral blood of a patient demonstrating clinical signs of bloodstream infection.
Control group (n=306; 277 analysed). The
insertion site for both control and experimental patients was cleansed with
either chlorhexidine 0.25% and benzalkonium 0.025% or chlorhexidine 2% or
povidone-iodone 7.5%. Most patients had iodine rather than the more effective
chlorhexidine. The same treatment was applied at each dressing change, which
occurred every 48 hours or more often if the dressing was damp or dirty. All
control patients were implanted with a double-lumen, non-heparin-bonded, 16cm
long Multi-Med CVC (Edwards Life Sciences), a polyurethane catheter treated with
benzalkonium chloride. Experimental group (n=301; 268 analysed). These patients received a double-lumen, non-heparin-bonded 16cm long Vantex Oligon CVC (Edwards Life Sciences), which is a catheter extruded from polyurethane and combined with silver, carbon and platinum.
The Evidence:
EBM questions:
1) Do the methods allow accurate testing of the hypothesis? Yes
2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes
3) Are conclusions valid in light of the results? Yes
4) Did results get omitted, and why? Yes. A total of 607 patients were enrolled, but 29 cases were missed in the control group (10 due to catheter contamination during removal, 19 due to non-cultured catheters), and 33 in the experimental group (12 due to catheter contamination during removal, 20 due to non-cultured catheters, 1 due to intra-operative death).
5) Did they suggest areas of further research? Yes. The authors admit the study was under-powered due to a low rate of event of catheter-related bloodstream infection. They estimate that 7000 study patients are required to overcome this.
6) Did they make any recommendations based on the results and were they appropriate? No specific recommendations, just further research required.
7) Is the study relevant to my clinical practice? Yes
8) What level of evidence does this study represent? 1-
9) What grade of recommendation can I make on this result alone? None
10) What grade of recommendation can I make when this study is considered along with other available evidence? None.
11) Should I change my practice because of these results? No. Not until further research has shown that Oligon-impregnated CVCs reduce bloodstream infection and not just colonisation.
12) Should I audit my current practice because of these results? No
Appraised by Dr D Swann, Consultant, Intensive Care, Royal Infirmary of Edinburgh. 2006.
Email: d.g.swann@ed.ac.uk
Kill or update by 2010 Reviewed & edited by CC & SJM
Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. 2006 & JICS 2006. Swann DG. Ranucci M, et al. Impact of oligon central venous catheters on catheter colonization and catheter-related bloodstream infection. Crit Care Med 2003; 31: 52-9.
©SICS EBM 2006
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