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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
Centre National de Greffe de Moelle Osseuse
About
Eligibility
Locations
Outcomes
Full info

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

4 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 19, 2006
    Last Updated
    January 26, 2009
    Sponsor
    Centre National de Greffe de Moelle Osseuse
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    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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