Prevention of Catheter-Related Bloodstream Infection in Patients With Hemato-Oncological Disease

This study has been completed.
Sponsor:
Information provided by:
Centre National de Greffe de Moelle Osseuse
ClinicalTrials.gov Identifier:
NCT00413738
First received: December 19, 2006
Last updated: January 26, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Infection
Device: Antiseptic-coated central venous catheters
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre National de Greffe de Moelle Osseuse:

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...)

Study Start Date: December 2006
Estimated Study Completion Date: January 2009
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.

  Eligibility

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413738

Sponsors and Collaborators
Centre National de Greffe de Moelle Osseuse
Investigators
Principal Investigator: Abderrahman Abdelkefi, MD Centre National de Greffe de Moelle Osseuse
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00413738     History of Changes
Other Study ID Numbers: Catheters04
Study First Received: December 19, 2006
Last Updated: January 26, 2009
Health Authority: Tunisia: Ministry of Public Health

Keywords provided by Centre National de Greffe de Moelle Osseuse:
Central venous catheter
Catheter related bloodstream infection
Heparin
Chlorhexidine
Sulfadiazine

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014