Prevention of Catheter-Related Bloodstream Infection in Patients With Hemato-Oncological Disease
Primary Purpose
Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Antiseptic-coated central venous catheters
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring Central venous catheter, Catheter related bloodstream infection, Heparin, Chlorhexidine, Sulfadiazine
Eligibility Criteria
Inclusion Criteria:
- Patients are eligible for the study if they are between 4 and 65 years of age and have a short-term non-tunneled percutaneous CVL.
Exclusion criteria:
- The presence of a CVL at admission
- An anticipated duration of catheterization of less than 5 days or more than 35 days
- A contraindication to the use of subclavian catheterization due to major blood coagulation disorders (ie, platelet count < 50 x 10^9/L)
- Disseminated intravascular coagulation
- Prior allergic reactions to heparin or to CSS
- An aberrant course of the CVL (jugular vein)
- An absence of catheter-tip culture at the time of catheter removal.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary outcome of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with hemato-oncological disease:
Group A: heparin-coated central venous catheters (Control Group)
Group B: antiseptic-coated (chlorhexidine-silver sulfadiazine) central venous catheters
Secondary Outcome Measures
Analysis of variables that may be significant for the development of CRBI (age, gender, underlying disease...)
Full Information
NCT ID
NCT00413738
First Posted
December 19, 2006
Last Updated
January 26, 2009
Sponsor
Centre National de Greffe de Moelle Osseuse
1. Study Identification
Unique Protocol Identification Number
NCT00413738
Brief Title
Prevention of Catheter-Related Bloodstream Infection in Patients With Hemato-Oncological Disease
Official Title
Prevention of Catheter-Related Bloodstream Infection in Patients With Hemato-Oncological Disease.A Randomized Controlled Trial:Heparin-Coated Central Venous Catheters Versus Antiseptic-Coated Central Venous Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centre National de Greffe de Moelle Osseuse
4. Oversight
5. Study Description
Brief Summary
The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with hemato-oncological disease:
Group A: heparin-coated central venous catheters (Control Group) Group B: antiseptic-coated (chlorhexidine-silver sulfadiazine) central venous catheters
Detailed Description
Central venous lines (CVLs) are commonly used in patients with hemato-oncological disease for indications such as monitoring of hemodynamics and administration of blood products, chemotherapy, parenteral nutrition, and infusion fluids. Complications of catheterization include mechanical (arterial puncture, pneumothorax), thrombotic and infectious complications.Data from the National Nosocomial Infections Surveillance system (US) between January 1992 and February 1998 showed that catheter-related bloodstream infection (CRBI) is the third most frequent nosocomial infection and accounts for 14% of all nosocomial infections. CRBIs prolong hospital stays from 7 to 21 days and account for an estimated increase in hospital costs of $ 3000-40 000 per patient.In addition, an estimated 10-20% attributable mortality owing to nosocomial CRBI has been reported.
Besides the aseptic measures both for the insertion of the catheter and its maintenance, many different approaches have been attempted to decrease central venous catheter infections: heparin-coated catheters, as well as antimicrobial and antiseptic impregnated CVLs.
Heparin-coated catheters:
Studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. Interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections.
Antiseptic-coated catheters:
Catheter colonization is an essential prerequisite in the pathogenesis of CRBI. Colonization results from contamination of the catheters during insertion and subsequent care. There are data to suggest that contamination often occurs at the time of insertion. Therefore, attempts to prevent colonization focus on the elimination of initial contamination through aseptic technique and on the retardation of subsequent migration of organisms into the bloodstream.
Recently, catheters impregnated with chlorhexidine and silver sulfadiazine have been developed to reduce the risk of catheter-related sepsis. Initial studies on humans showed that such impregnation could effectively reduce colonization in short-term catheterisation, but they have been less conclusive in showing the benefit of such impregnation in reducing catheter-related bloodstream infections.The efficacy of these antiseptic catheters varies in different subgroup populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Central venous catheter, Catheter related bloodstream infection, Heparin, Chlorhexidine, Sulfadiazine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Antiseptic-coated central venous catheters
Primary Outcome Measure Information:
Title
The primary outcome of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with hemato-oncological disease:
Title
Group A: heparin-coated central venous catheters (Control Group)
Title
Group B: antiseptic-coated (chlorhexidine-silver sulfadiazine) central venous catheters
Secondary Outcome Measure Information:
Title
Analysis of variables that may be significant for the development of CRBI (age, gender, underlying disease...)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are eligible for the study if they are between 4 and 65 years of age and have a short-term non-tunneled percutaneous CVL.
Exclusion criteria:
The presence of a CVL at admission
An anticipated duration of catheterization of less than 5 days or more than 35 days
A contraindication to the use of subclavian catheterization due to major blood coagulation disorders (ie, platelet count < 50 x 10^9/L)
Disseminated intravascular coagulation
Prior allergic reactions to heparin or to CSS
An aberrant course of the CVL (jugular vein)
An absence of catheter-tip culture at the time of catheter removal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abderrahman Abdelkefi, MD
Organizational Affiliation
Centre National de Greffe de Moelle Osseuse
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
15640824
Citation
Abdelkefi A, Achour W, Ben Othman T, Torjman L, Ladeb S, Lakhal A, Hsairi M, Kammoun L, Ben Hassen A, Ben Abdeladhim A. Difference in time to positivity is useful for the diagnosis of catheter-related bloodstream infection in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2005 Feb;35(4):397-401. doi: 10.1038/sj.bmt.1704773.
Results Reference
background
PubMed Identifier
16258088
Citation
Abdelkefi A, Torjman L, Ladeb S, Othman TB, Achour W, Lakhal A, Hsairi M, Kammoun L, Hassen AB, Abdeladhim AB. Randomized trial of prevention of catheter-related bloodstream infection by continuous infusion of low-dose unfractionated heparin in patients with hematologic and oncologic disease. J Clin Oncol. 2005 Nov 1;23(31):7864-70. doi: 10.1200/JCO.2004.00.9787.
Results Reference
background
PubMed Identifier
16151418
Citation
Abdelkefi A, Ben Romdhane N, Kriaa A, Chelli M, Torjman L, Ladeb S, Ben Othman T, Lakhal A, Guermazi S, Ben Hassen A, Ladeb F, Ben Abdeladhim A. Prevalence of inherited prothrombotic abnormalities and central venous catheter-related thrombosis in haematopoietic stem cell transplants recipients. Bone Marrow Transplant. 2005 Nov;36(10):885-9. doi: 10.1038/sj.bmt.1705156.
Results Reference
background
PubMed Identifier
15351864
Citation
Abdelkefi A, Ben Othman T, Kammoun L, Chelli M, Romdhane NB, Kriaa A, Ladeb S, Torjman L, Lakhal A, Achour W, Ben Hassen A, Hsairi M, Ladeb F, Ben Abdeladhim A. Prevention of central venous line-related thrombosis by continuous infusion of low-dose unfractionated heparin, in patients with haemato-oncological disease. A randomized controlled trial. Thromb Haemost. 2004 Sep;92(3):654-61. doi: 10.1160/TH04-02-0087.
Results Reference
background
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Prevention of Catheter-Related Bloodstream Infection in Patients With Hemato-Oncological Disease
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