CATCH - Catheter Infections in Children

Institute of Child Health

Status and phase: Completed; Phase 3

Conditions: Catheter-related Infections

Treatments: Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin); Device: Heparin bonded polyurethane CVC; Device: Standard polyurethane Central Venous Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01029717

08EB20

Details and patient eligibility

About

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.

Enrollment: 1,859 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,859 participants in 3 patient groups

Standard polyurethane Central Venous Catheter

Experimental group

Description:

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

Treatment:

Device: Standard polyurethane Central Venous Catheter

Antibiotic impregnated polyurethane CVC

Active Comparator group

Description:

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

Treatment:

Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)

Heparin bonded polyurethane CVC

Active Comparator group

Description:

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

Treatment:

Device: Heparin bonded polyurethane CVC