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

NCT00550693 | Completed Phase 4 DMC

• 2 other identifiers: Biopatch 400-05-005WUSM HRPO 04-1312
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

Catheter Related Bloodstream Infection

Keywords

bloodstream infections; hemodialysis catheter

Outcome Measures

Primary Outcomes (1)

• Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions

  over a six-month period

Secondary Outcomes (1)

• 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

Study Arms (1)

A

PLACEBO COMPARATOR

The patients in this arm continued with the local catheter care protocol.

Device: Chlorhexidine-impregnated foam dressing

Interventions

Chlorhexidine-impregnated foam dressing DEVICE

Patients during the intervention period had this foam dressing applied around their central venous catheter. This was replaced once a week as recommended by the package insert unless the dressing was soiled, bloody, or fell off.

Also known as: Biopatch Antimicrobial Dressing

A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Barnes-Jewish Dialysis Center

St Louis, Missouri, 63108, United States

Location

Chromalloy American Kidney Center

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard C Camins, MD, MSCR

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: April 1, 2004
• Study Completion: March 1, 2005
• Last Updated: October 30, 2007

Record last verified: 2007-10

Locations

US (2)