Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients

Completed · Phase 4

Conditions studied: Catheter Related Bloodstream Infection

In brief

There are currently no published data on the efficacy of the chlorhexidine-impregnated foam dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients. The researchers perfomed a cross-over intervention trial on patients who were dialyzed through central venous catheters at two outpatient dialysis centers were enrolled. The use of a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol during the intervention period. A nested cohort study of all patients who received the foam dressing was also conducted to determine independent risk factors for development of BSI. The primary outcomes were the catheter-related bloodstream infection rates in the intervention and control groups. Secondary outcomes include the clinical sepsis rates between the two groups and risk factors for development of bloodstream infection despite the use of the foam dressing.

Key facts

Study ID

NCT00550693

Run by

Washington University School of Medicine

People needed

121

Starts

2004-04-01

Expected to finish

2005-03-01

Last updated by the study team

2007-10-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients who were dialyzed through a central venous catheter during the time period

You may not qualify if…

• Patients who were allergic to chlorhexidine

Where it is running

• Barnes-Jewish Dialysis Center — St Louis, Missouri, United States
• Chromalloy American Kidney Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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