CATCH - Catheter Infections in Children

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Catheter-related Infections

Intervention / Treatment
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* Device: Standard polyurethane Central Venous Catheter
* Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
* Device: Heparin bonded polyurethane CVC


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard polyurethane Central Venous Catheter<br>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<br>* Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.<br>|
| Active Comparator: Antibiotic impregnated polyurethane CVC<br>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)<br>* Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.<br>|
| Active Comparator: Heparin bonded polyurethane CVC<br>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<br>* Heparin bonded polyurethane CVC. All CVCs used in the trial are CE marked medical devices used for their intended purpose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Venous Catheters, blood stream infection, children, intensive care, Heparin bonded, antibiotic coated, Children in Paediatric Intensive Care Unit