CATCH - Catheter Infections in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Institute of Child Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT01029717
First received: December 9, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 9, 2009
December 9, 2009
January 2010
December 2012   (final data collection date for primary outcome measure)
The primary outcome will be time to first blood stream infection defined by a positive blood culture from a sample that was clinically indicated and taken more than 48 hours after CVC insertion and up to 48 hours after CVC removal. [ Time Frame: 48 HOURS ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
CATCH - Catheter Infections in Children
A Randomised Controlled Trial Comparing the Effectiveness of Heparin Bonded or Antibiotic Impregnated Central Venous Catheters (CVCs) With Standard CVCs for the Prevention of Hospital Acquired Blood Stream Infection in Children

Most children admitted to paediatric intensive care units (PICU) need to have medicines given to them into their veins using a narrow tube, so they do not need repeated injections. This tube is called a central venous catheter. Occasionally these catheters can cause infections in the blood and sometimes the tubes can get blocked by small blood clots.

Some intensive care units already use antibiotic or heparin coated catheters, but there is no proof that these are better than the standard ones at preventing infections. Most of the PICU's in this country use standard lines. The only way to find out for certain is to compare children who are given antibiotic or heparin coated catheters with those who are given standard ones in a clinical trial. Because we do not know which type of catheter is best, the type of catheter each child receives in the study will be decided randomly by chance.

Each child in the trial will have the same chance of getting any of these three catheters:

  • Standard central venous catheter (not coated).
  • Heparin coated central venous catheter. Heparin is a medicine that can stop blood from clotting and might stop the tubes being blocked and infections in the blood.
  • Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria which cause the infections.

The aim of this study is to see how the three types of catheters compare in reducing the amount of blood infections in children. We will also look at the costs involved. We hope to recruit 1200 children in the UK over 2 years. We hope that the information we get from this study will guide policy about purchasing impregnated Central Venous Catheters across the NHS and thereby improve treatment for children in the future.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Catheter-Related Infections
  • Device: Standard polyurethane Central Venous Catheter
    Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.
  • Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
    Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
  • Device: Heparin bonded polyurethane CVC
    Heparin bonded polyurethane CVC. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
  • Experimental: Standard polyurethane Central Venous Catheter

    Standard polyurethane Central Venous Catheter

    All CVCs used in the trial are CE marked medical devices used for their intended purpose.

    Intervention: Device: Standard polyurethane Central Venous Catheter
  • Active Comparator: Antibiotic impregnated polyurethane CVC

    Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)

    All CVCs used in the trial are CE marked medical devices used for their intended purpose.

    Intervention: Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
  • Active Comparator: Heparin bonded polyurethane CVC

    Heparin bonded polyurethane CVC

    All CVCs used in the trial are CE marked medical devices used for their intended purpose.

    Intervention: Device: Heparin bonded polyurethane CVC
Pierce CM, Wade A, Mok Q. Heparin-bonded central venous lines reduce thrombotic and infective complications in critically ill children. Intensive Care Med. 2000 Jul;26(7):967-72.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1200
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Weighing ≥3kg and less than 16 years of age;
  • Admitted to or being prepared for admission to an intensive care unit participating in the trial;
  • Require insertion of a polyurethane CVC as part of good clinical management;
  • Require one of the CVC sizes available to the trial (see Appendix A for the list of CVCs);
  • Expected to require a CVC for at least 3 days;
  • Appropriate consent obtained (prospective consent for elective surgical patients, deferred consent for emergency admission patients).
Both
up to 16 Years
No
Contact: Tracy Ball +44 (0)20 74058207
United Kingdom
 
NCT01029717
08EB20
No
RESEARCH AND DEVELOPMENT OFFICE, INSTITUTE OF CHILD HEALTH
Institute of Child Health
Not Provided
Study Director: Ruth Gilbert, Professor Institute of Child Health
Institute of Child Health
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP