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

Phase 4

Completed

• Conditions: Catheter Related Bloodstream Infection
• Interventions: Device: Chlorhexidine-impregnated foam dressing

• Registration Number: NCT00550693
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-03
• Status Verified: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Last Update Submitted: 2007-10-29
• Study First Posted: 2007-10-30
• Last Update Posted: 2007-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

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

Exclusion Criteria

• Patients who were allergic to chlorhexidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Chlorhexidine-impregnated foam dressing	The patients in this arm continued with the local catheter care protocol.

Primary Outcome Measures

Name	Time	Method
Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions	over a six-month period

Secondary Outcome Measures

Name	Time	Method
clinical sepsis rates between the two groups; exit site infection rates between the two groups; adverse events related to the intervention	over a 6 month period

Trial Locations

Locations (2)

Barnes-Jewish Dialysis Center; 🇺🇸 Saint Louis, Missouri, United States

Chromalloy American Kidney Center; 🇺🇸 Saint Louis, Missouri, United States