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© SICS EBM Group 2004
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Do antiseptic impregnated central lines prevent catheter-related bloodstream infection?
Lead author's name: Bruin-Buisson C
Three-part Clinical Question: Patients: ICU patients Intervention: antiseptic impregnation of the inner & outer surfaces of central venous catheters with silver sulphadiazine and chlorhexidine or untreated central venous catheters Outcomes: catheter colonisation and catheter-related infection including definite CRBSI, probable CRBSI (blood culture of a typical organism without a primary source and non-bacteraemic catheter-related sepsis (resolution of clinical features within 2 days of removal of CVC)
Search Terms: intensive care, critical care, central venous catheters, infection, prevention, controlled trial
The Study: Randomised, controlled trial, with intention-to treat analysis
The Study Patients: 397 patients, of whom 31 were lost to the study. Control group n = 175 patients; all analysed.
Untreated CVCs.
The Evidence:
EBM Questions:
1) Do the methods allow accurate testing of the hypothesis? No, the study was under-powered to detect a difference in catheter-related infection rates.
2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? A power calculation was done. To detect a reduction in catheter-related infection rates from 10 to 5%, with a 5% alpha risk and an 80% power, 1 000 patients would need to be studied. Even more would be needed to detect differences in the clinically more meaningful CRBSI rates. As the authors discuss, recruitment to this trial was slow and many patients who were recruited were at low risk of catheter-related infection. A type II error may therefore explain the results – too few patients were recruited to test the hypothesis.
3) Are conclusions valid in light of the results? Yes. The conclusions that antiseptic catheters were associated with a significant reduction in catheter colonisation, a trend to a reduction in infection episodes, but not of CRBSIs were valid.
4) Did results get omitted, and why? Yes There were 31 unexplained drop-outs; 3 cultures were not done in the experimental group.
5) Did they suggest areas of further research? Yes. The authors suggested that a trial to compare externally-coated chlorhexidine catheters and impregnated chlorhexidine catheters would be very difficult to perform.
6) Did they make any recommendations based on the results and were they appropriate? No. There was no recommendation to use the antiseptic catheter.
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? N/A.
10) What grade of recommendation can I make when this study is considered along with other available evidence? A
11) Should I change my practice because of these results? Perhaps- it depends on your views about the validity and importance of pooled analysis of RCTs
12) Should I audit my current practice because of these results? No, but you should be auditing CRBSI rates anyway.
Appraised by Dr David Swann, Consultant, ICU, Royal Infirmary of Edinburgh.
Email: d.g.swann@ad.ac.uk
June 2005 Kill by Date: 2010
©SICS EBM 2005
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