CATCH - CATheter Infections in CHildren
| ISRCTN | ISRCTN34884569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34884569 |
| ClinicalTrials.gov number | NCT01029717 |
| Secondary identifying numbers | HTA 08/13/47; 08EB20 |
- 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
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
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
| r.gilbert@ich.ucl.ac.uk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/09/2010 |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
WC1N 1EH
United Kingdom
Sponsor information
Research organisation
University College London
30 Guildford Street
London
WC1N 1EH
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
Editorial Notes
18/12/2019: Publication reference added.
08/03/2016: Publication reference added.
