Back to resultsTrial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Primary Purpose
Catheter Related Bloodstream Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine-impregnated foam dressing
Sponsored by
About this trial
This is an interventional treatment trial for Catheter Related Bloodstream Infection focused on measuring bloodstream infections, hemodialysis catheter
Eligibility Criteria
Inclusion Criteria:
- All patients who were dialyzed through a central venous catheter during the time period
Exclusion Criteria:
- Patients who were allergic to chlorhexidine
Sites / Locations
- Barnes-Jewish Dialysis Center
- Chromalloy American Kidney Center
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
A
Arm Description
The patients in this arm continued with the local catheter care protocol.
Outcomes
Primary Outcome Measures
Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions
Secondary Outcome Measures
clinical sepsis rates between the two groups; exit site infection rates between the two groups; adverse events related to the intervention
Full Information
NCT ID
NCT00550693
First Posted
October 29, 2007
Last Updated
October 29, 2007
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00550693
Brief Title
Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Official Title
A Crossover Intervention Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Bloodstream Infection
Keywords
bloodstream infections, hemodialysis catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
The patients in this arm continued with the local catheter care protocol.
Intervention Type
Device
Intervention Name(s)
Chlorhexidine-impregnated foam dressing
Other Intervention Name(s)
Biopatch Antimicrobial Dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions
Time Frame
over a six-month period
Secondary Outcome Measure Information:
Title
clinical sepsis rates between the two groups; exit site infection rates between the two groups; adverse events related to the intervention
Time Frame
over a 6 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who were dialyzed through a central venous catheter during the time period
Exclusion Criteria:
Patients who were allergic to chlorhexidine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard C Camins, MD, MSCR
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Dialysis Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Chromalloy American Kidney Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
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