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04 February 2012
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| [ Print-friendly version ] |
| CATCH - CATheter Infections in CHildren |
| ISRCTN | ISRCTN34884569 |
| ClinicalTrials.gov identifier | NCT01029717 |
| Public title | CATCH - CATheter Infections in CHildren |
| 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 |
| Serial number at source | HTA 08/13/47; 08EB20 |
| Study hypothesis |
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: 1. Standard central venous catheter (not coated). 2. 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. 3. 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. Protocol can be found at http://www.hta.ac.uk/protocols/200800130047.pdf |
| Lay summary | |
| Ethics approval | South West Medical Research Ethics Committee (MREC) approved on the 19th of February 2010 (ref: 09/H0206/69) |
| Study design | Multicentre 3 arm double blind (patients and PICU staff) randomised active controlled trial. Unblinded to randomising/inserting clinician |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Children in Paediatric Intensive Care |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2010 |
| Anticipated end date | 01/03/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 1200 |
| Interventions |
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. |
| 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 |
| 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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) (ref: 08/13/47) |
| Trial website | http://www.catchtrial.org.uk |
| Publications | |
| Contact name | Prof Ruth Gilbert |
| Address |
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 |
| City/town | London |
| Zip/Postcode | WC1N 1EH |
| Country | United Kingdom |
| r.gilbert@ich.ucl.ac.uk | |
| Sponsor | Institute of Child Health (UK) |
| Address |
University College London
30 Guildford Street |
| City/town | London |
| Zip/Postcode | WC1N 1EH |
| Country | United Kingdom |
| Tel | +44 (0)207 905 2179 |
| Fax | +44 (0)207 905 2201 |
| Date applied | 10/08/2010 |
| Last edited | 25/11/2010 |
| Date ISRCTN assigned | 12/08/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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