Details of HTA project starting soon
Last updated: 16 March 2010 - Next update due: 23 March 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 and Director, Centre for Evidence Based Child Health, University College London |
Start Date: |
January 2010. Project is due to start on this date but could be subject to delays. |
Publication date: |
Early 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: |
DESIGN: The study will be a pragmatic, 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. SETTING: The study will take place in the 10 largest Paediatric Intensive Care Units (PICUs) in the UK with more than 600 admissions per year. 6 of the 10 centres fall within the Medicines for Children Local Research Networks. REVIEW OF THE LITERATURE: Central venous catheters (CVCs) are widely used in the NHS with an estimated 238,000 inserted each year. CVCs are used in intensive and high dependency care to provide venous access for resuscitation, drug delivery, intravenous feeding, monitoring, and blood sampling. Their main disadvantage is nosocomial infection Nine systematic reviews and at least 37 randomised controlled trials (11,586 patients) demonstrate substantial benefits of impregnated compared with standard CVCs for catheter related bloodstream infection. The most recent review shows that heparin bonded or antibiotic impregnated CVCs offer the most effective options. Heparin coated CVCs act by reducing thrombus formation and bacterial adherence to thrombus, but the bonding agent, benzalkonium chloride, also has anti-infective properties. Antibiotic impregnated CVCs act by preventing biofilm formation and thereby prevention bacterial colonisation. These interventions have never been directly compared. A recent HTA cost effectiveness estimated that impregnated CVCs could be cost saving given a wide range of assumptions about baseline risk and additional cost. However, these conclusions relate to studies in adults and may not be applicable to children. The need for a further trial in children that compares impregnated and standard CVCs is based on: the lack of trials comparing antibiotic impregnated with standard CVCs in children; lack of evidence for whether benefits of impregnated CVCs persist in the context of strenuous efforts to reduce CVC infection through the use of catheter care bundles; the poor quality of previous studies may have overestimated treatment effects; the intrinsic bias in the use of catheter related blood stream infection as the outcome in all trials, which likely overestimates effect size; failure to consider all blood stream infections as an outcome in previous trial;, and the need to compare impregnated CVCs with standard to quantify benefits and costs for the NHS. TARGET POPULATION: The target population is children admitted to PICU, most of whom require a CVC. Across all UK PICUs almost half the admissions (47%) are for infants and of these around one-third are neonates. Two broad clinical groups will be defined for the trial: planned surgical admissions (about one-third of all admissions) and emergency admissions HEALTH TECHNOLOGIES ASSESSED: We will compare standard polyurethane CVCs with antibiotic impregnated (minocycline and rifampicin) and heparin coated polyurethane CVCs. Participants will be randomly allocated to receive a standard, antibiotic impregnated or heparin coated CVC in a ratio of 1:1:1. All CVCs used in the trial are CE marked medical devices, used in some PICUs in the UK. MEASUREMENT OF COSTS AND OUTCOMES: The primary outcome will be the proportion of children with a blood stream infection while the CVC inserted during the trial is in situ. Blood stream infection will be defined by a positive blood culture from a sample that was clinically indicated and taken more than 48 hours after CVC insertion and before CVC removal. Secondary outcomes will be: a)Time to first blood stream infection b)Rate of blood stream infection during CVC insertion per 1000 CVC days. c)Time to repeated blood stream infection based on culture d)Time to CVC related blood stream infection based on culture e)Time to high bacterial DNA load indicative of blood stream infection f)Time to culture negative infection based on clinical criteria |
Project Protocol: |
Project protocol not available |
URL of this page: |
http://www.hta.ac.uk/1867 |
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