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

January 26, 2009 updated by: Centre National de Greffe de Moelle Osseuse

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Analysis of variables that may be significant for the development of CRBI (age, gender, underlying disease...)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre National de Greffe de Moelle Osseuse

Investigators

  • Principal Investigator: Abderrahman Abdelkefi, MD, Centre National de Greffe de Moelle Osseuse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion

January 1, 2009

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 20, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2009

Last Update Submitted That Met QC Criteria

January 26, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Catheters04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Clinical Trials on Antiseptic-coated central venous catheters

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe