Condition category
Not Applicable
Date applied
10/08/2010
Date assigned
12/08/2010
Last edited
08/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
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. Heparin is a medicine that can stop blood from clotting and might stop the tubes getting blocked. Antibiotics can be used to kill the bacteria which cause the infections. However, there is no proof that these coated catheters are better than the standard ones at preventing infections. Most of the PICUs 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. The aim of this study is to see how three types of catheters compare at reducing the amount of blood infections in children. We will also look at the costs involved.

Who can participate?
Children less than 16 years of age who are admitted to an intensive care unit participating in the study and require insertion of a central venous catheter for at least 3 days.

What does the study involve?
Because we do not know which type of catheter is best, the type of catheter each child receives in the study is decided randomly by chance. Each child in the study has the same chance of getting any of these three catheters: a standard central venous catheter (not coated), a heparin-coated central venous catheter, or an antibiotic-coated central venous catheter.

What are the possible benefits and risks of participating?
We hope that the information we get from this study will guide policy about purchasing coated central venous catheters across the NHS and thereby improve treatment for children in the future.

Where is the study run from?
University College London - Institute of Child Health (UK)

When is the study starting and how long is it expected to run for?
September 2010 to March 2013

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof. Ruth Gilbert
r.gilbert@ich.ucl.ac.uk

Trial website

http://www.catchtrial.org.uk

Contact information

Type

Scientific

Primary contact

Prof Ruth Gilbert

ORCID ID

Contact details

Professor of Clinical Epidemiology
Director
Centre for Evidence-based Child Health
Centre for Paediatric Epidemiology and Biostatistics
University College London - Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
-
r.gilbert@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01029717

Protocol/serial number

HTA 08/13/47; 08EB20

Study information

Scientific title

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

Acronym

CATCH

Study hypothesis

To determine the effectiveness of heparin bonded or antibiotic impregnated CVCs compared with standard CVCs for preventing hospital acquired blood stream infection.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081347
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0015/52206/PRO-08-13-47.pdf

Ethics approval

South West Medical Research Ethics Committee (MREC), 19/02/2010, ref: 09/H0206/69

Study design

Multicentre three-arm double-blind (patients and PICU staff) randomised active controlled trial. Unblinded to randomising/inserting clinician

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Children in Paediatric Intensive Care

Intervention

Ratio of 1:1:1
1. Standard polyurethane Central Venous Catheter,
2. Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
3. Heparin bonded polyurethane CVC

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

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Rate of blood stream infection during CVC insertion per 1000 CVC days
2. Time to CVC thrombosis defined clinically
3. Time to a composite measure of blood stream infection based on the primary outcome or high bacterial DNA load or culture negative bloodstream infection based on clinical criteria
4. Mortality by 30 days
5. Type of bacteria and fungi isolated from positive blood cultures
6. Resistance to minocycline or rifampicin of blood culture or CVC tip isolate
7. Unexplained thrombocytopenia after insertion of CVC detected by routine laboratory monitoring
8. Time to randomised CVC removal
9. Length of stay requiring PICU
10. Total length of hospital stay for current episode (for up to 6 month post randomisation)
11. Cost effectiveness of heparin bonded vs. antibiotic impregnated vs. standard CVCs

Overall trial start date

01/09/2010

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Less than 16 years of age
2. Admitted to or being prepared for admission to an intensive care unit participating in the trial
3. Requires insertion of a central venous catheter
4. Requires one of the central venous catheter sizes available to the trial
5. Expected to require a central venous catheter for at least 3 days

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Previously enrolled in the CATCH trial
2. Has a known allergy or hypersensitivity to tetracyclines (including minocycline), rifampicin or heparin?
3. Patient known to be pregnant
4. Patient known to have a history of heparin induced thrombocytopenia
5. Patient is in a randomised controlled trial that excludes participation in CATCH

Recruitment start date

01/09/2010

Recruitment end date

01/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London - Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Institute of Child Health (UK)

Sponsor details

University College London
30 Guildford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme (ref: 08/13/47)

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/03/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26946925

Publication citations

Additional files

Editorial Notes

08/03/2016: Publication reference added.