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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413738
• Other study ID #: Catheters04
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2006
• Last updated: January 26, 2009
• Start date: December 2006
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Centre National de Greffe de Moelle Osseuse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Device:
• Antiseptic-coated central venous catheters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre National de Greffe de Moelle Osseuse

References & Publications (4)

Abdelkefi A, Achour W, Ben Othman T, Torjman L, Ladeb S, Lakhal A, Hsaïri 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. — View 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, Hsaïri 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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:
Primary	Group A: heparin-coated central venous catheters (Control Group)
Primary	Group B: antiseptic-coated (chlorhexidine-silver sulfadiazine) central venous catheters
Secondary	Analysis of variables that may be significant for the development of CRBI (age, gender, underlying disease...)