CATCH - Catheter Infections in Children

NCT01029717 | Completed Phase 3

• 1 other identifier: 08EB20
• Study Type: interventional
• Target: 1,859
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter-related Infections

Keywords

Central Venous Catheters; blood stream infection; children, intensive care; Heparin bonded; antibiotic coated; Children in Paediatric Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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.

  48 HOURS

Study Arms (3)

Standard polyurethane Central Venous Catheter

EXPERIMENTAL

Standard polyurethane Central Venous Catheter All CVCs used in the trial are CE marked medical devices used for their intended purpose.

Device: Standard polyurethane Central Venous Catheter

Antibiotic impregnated polyurethane CVC

ACTIVE COMPARATOR

Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) All CVCs used in the trial are CE marked medical devices used for their intended purpose.

Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)

Heparin bonded polyurethane CVC

ACTIVE COMPARATOR

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

Device: Heparin bonded polyurethane CVC

Interventions

Standard polyurethane Central Venous Catheter DEVICE

Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.

Standard polyurethane Central Venous Catheter

Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) DEVICE

Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.

Antibiotic impregnated polyurethane CVC

Heparin bonded polyurethane CVC DEVICE

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

Heparin bonded polyurethane CVC

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

Sponsors & Collaborators

• Institute of Child Health: lead

Study Sites (1)

Institute of Child Health

London, WC1N 1EH, United Kingdom

Location

Related Publications (3)

• 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. doi: 10.1007/s001340051289.

  PMID: 10990114 BACKGROUND

• Harron K, Mok Q, Dwan K, Ridyard CH, Moitt T, Millar M, Ramnarayan P, Tibby SM, Muller-Pebody B, Hughes DA, Gamble C, Gilbert RE. CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children. Health Technol Assess. 2016 Mar;20(18):vii-xxviii, 1-219. doi: 10.3310/hta20180.

  PMID: 26935961 RESULT

• Harron K, Woolfall K, Dwan K, Gamble C, Mok Q, Ramnarayan P, Gilbert R. Deferred Consent for Randomized Controlled Trials in Emergency Care Settings. Pediatrics. 2015 Nov;136(5):e1316-22. doi: 10.1542/peds.2015-0512. Epub 2015 Oct 5.

  PMID: 26438711 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Ruth Gilbert, Professor

  Institute of Child Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

GB (1)