Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
CATheter Infections in Children - the CATCH trial |
Project ref: |
08/13/47 |
Cost: |
£1,712,753 |
Chief Investigator : |
Professor Ruth Gilbert, Professor of Clinical Epidemiology, Centre of Paediatric Epidemiology and Biostatistics, University College London |
Start Date: |
March 2010 |
Estimated date of publication in HTA journal series: |
Mid 2014. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Most children who are admitted to intensive care units need to have their medicines given to them into their veins. Because these children are sick and may need fluids and medicines given into their veins urgently if they suddenly deteriorate, they will usually have a central venous catheter (CVC) put in place. A CVC is narrow tube that stays in place in a large vein so avoiding the need for repeated injections and ensuring that fluids and medicines can be given quickly in an emergency. Unfortunately, CVCs can cause blood stream infections which are usually treated with antibiotics and need a longer stay in the intensive care unit. In children, CVCs have to be small, so are more likely to develop small clots in their channels, making it easier for bacteria to attach and cause blood stream infection. It is suggested that when the CVC is coated with either an antibiotic, to kill bacteria, or heparin, which is an anti-clotting medicine, then this will reduce the possibility of blood stream infections occurring. Reducing the risk of blood stream infections as a result of CVC insertion is a major focus of a Department of Health strategy. The Dept of Health guidelines recommend considering the use of antibiotic coated CVCs if the risk of catheter related blood stream infection is high, but this recommendation applies to adult patients as no research has been done to test whether the use of antibiotic coated CVCs reduce the risk of blood stream infection in children. Although there has been some research to test heparin coated CVCs in children, these lines are not mentioned in the guidelines at all. There has been a suggestion that the use of impregnated or coated CVCs may actually save money for the NHS by reducing the rate of blood stream infection and all of the problems related with this. A small number of paediatric intensive care units (PICUs) already use antibiotic or heparin CVCs, but there is no proof as to whether these are better than the standard CVCs when staff are already reducing the risk of infection by following stringent guidelines for improving the care of CVCs (called CVC care bundles). The only way to find out accurately is to carry out a randomised controlled trial. Ten of the largest paediatric intensive care units in England have agreed to take part. A third of the children will receive a CVC coated with heparin, a third with antibiotic and the final group will have a standard CVC. The CVCs will be allocated randomly, and although the clinician inserting it will know which it is, he or she will not normally be the person caring for the child in the PICU. So that the information provided about the CVCs is balanced and not swayed by knowledge of whether the child has a coated line or not, the child, parents and other staff will not know which of the three types of CVC has been used. This study will be performed in ten PICUs throughout the UK, by a network of doctors and research staff who are very experienced in carrying out studies in seriously ill children. Because part of this study involves treatment in an emergency situation, we will be requesting ethical approval for a deferred consent process for these participants. This means that the line will be inserted without any delay (so the trial does not cause a delay in starting treatment) but, once the patient's condition allows, consent will be sought from their parent/legal guardian, and assent from the child where appropriate, to continue the study and incorporate the patient's record into the study. From this trial we hope to find out whether PICUs should use impregnated CVCs or not and which type, antibiotic or heparin, is best for avoiding blood stream infections in children. |
Project Abstract: |
The trial is a pragmatic, Phas III, 3-arm randomised controlled clinical trial. Treatment allocation cannot be blinded to the clinician responsible for randomising a patient and inserting the central venous catheter (CVC) but will be concealed from patients, their parents and PICU personnel responsible for their care. Population: The study population is 1200 children less than 16 years of age admitted to PICU, who require insertion of a polyurethane CVC for at least 3 days, and who weigh more than 3 kg. We will recruit children from two broad clinical groups: children admitted as planned surgical admissions (about one-third of all admissions) and children admitted as an emergency from the same or another hospital. Approximately 40% of PICU admissions are expected to be eligible. Recruitment targets will be reached if 1 in 4 of these patients are enrolled. As this study involves treatment in an emergency situation, we will be requesting ethical approval for a deferred consent process for children admitted as an emergency. The line can then be inserted without any delay and consent/assent will be sought at 48 hours post randomisation, or once the patient's condition allows. The study will involve 10 UK Paediatric Intensive Care Units (PICUs). Study Duration: Patient follow-up until 48 hours after removal of the randomised CVC will be by the research nurse. Follow-up at 6 months will be ascertained from routine administrative data. Description of Agent/ Intervention: We will randomly allocate children to a standard polyurethane CVC, antibiotic impregnated CVC (minocycline and rifampicin), or heparin bonded polyurethane CVC. in a ratio of 1:1:1. Objectives: Primary: To determine the effectiveness of heparin bonded or antibiotic impregnated CVCs compared with standard CVCs for preventing hospital acquired blood stream infection. Secondary Objectives include: Cost effectiveness, effectiveness of type of CVC in 3-way comparison for preventing hospital acquired blood stream infection, effect of type of CVC on clinical measures of care (duration of CVC insertion, antibiotic use, and stay), mortality at 30 days and adverse events on pathogen selection, antibiotic resistance, clinical evidence of CVC thrombosis, and thrombocytopenia. |
ISRCTN* number: | ISRCTN 34884569 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN34884569 |
Project Protocol: |
Project protocol (pdf format, 817 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1867 |
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