CATCH - CATheter Infections in CHildren

ISRCTN	ISRCTN34884569
DOI	https://doi.org/10.1186/ISRCTN34884569
ClinicalTrials.gov (NCT)	NCT01029717
Protocol serial number	HTA 08/13/47; 08EB20
Sponsor	Institute of Child Health (UK)
Funder	Health Technology Assessment Programme (ref: 08/13/47)

Submission date: 10/08/2010
Registration date: 12/08/2010
Last edited: 18/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Ruth Gilbert
Scientific

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

Email	r.gilbert@ich.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre three-arm double-blind (patients and PICU staff) randomised active controlled trial. Unblinded to randomising/inserting clinician
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	CATCH
Study objectives	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(s)	South West Medical Research Ethics Committee (MREC), 19/02/2010, ref: 09/H0206/69
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/03/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	All
Target sample size at registration	1200
Key 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
Key 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
Date of first enrolment	01/09/2010
Date of final enrolment	01/03/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London - Institute of Child Health

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/04/2016		Yes	No
Other publications	post-hoc analysis of thrombosis risk	28/03/2019	18/12/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/12/2019: Publication reference added.
08/03/2016: Publication reference added.