CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children

Harron, Katie, Mok, Quen, Dwan, Kerry, Ridyard, Colin H, Moitt, Tracy ORCID: 0000-0002-5579-996X, Millar, Michael, Ramnarayan, Padmanabhan, Tibby, Shane M, Muller-Pebody, Berit, Hughes, Dyfrig A ORCID: 0000-0001-8247-7459
et al (show 2 more authors) (2016) CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children. HEALTH TECHNOLOGY ASSESSMENT, 20 (18). 1-+.

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<h4>Background</h4>Impregnated central venous catheters (CVCs) are recommended for adults to reduce bloodstream infection (BSI) but not for children.<h4>Objective</h4>To determine the effectiveness of impregnated compared with standard CVCs for reducing BSI in children admitted for intensive care.<h4>Design</h4>Multicentre randomised controlled trial, cost-effectiveness analysis from a NHS perspective and a generalisability analysis and cost impact analysis.<h4>Setting</h4>14 English paediatric intensive care units (PICUs) in England.<h4>Participants</h4>Children aged < 16 years admitted to a PICU and expected to require a CVC for ≥ 3 days.<h4>Interventions</h4>Heparin-bonded, antibiotic-impregnated (rifampicin and minocycline) or standard polyurethane CVCs, allocated randomly (1 : 1 : 1). The intervention was blinded to all but inserting clinicians.<h4>Main outcome measure</h4>Time to first BSI sampled between 48 hours after randomisation and 48 hours after CVC removal. The following data were used in the trial: trial case report forms; hospital administrative data for 6 months pre and post randomisation; and national-linked PICU audit and laboratory data.<h4>Results</h4>In total, 1859 children were randomised, of whom 501 were randomised prospectively and 1358 were randomised as an emergency; of these, 984 subsequently provided deferred consent for follow-up. Clinical effectiveness - BSIs occurred in 3.59% (18/502) of children randomised to standard CVCs, 1.44% (7/486) of children randomised to antibiotic CVCs and 3.42% (17/497) of children randomised to heparin CVCs. Primary analyses comparing impregnated (antibiotic and heparin CVCs) with standard CVCs showed no effect of impregnated CVCs [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.37 to 1.34]. Secondary analyses showed that antibiotic CVCs were superior to standard CVCs (HR 0.43, 95% CI 0.20 to 0.96) but heparin CVCs were not (HR 1.04, 95% CI 0.53 to 2.03). Time to thrombosis, mortality by 30 days and minocycline/rifampicin resistance did not differ by CVC. Cost-effectiveness - heparin CVCs were not clinically effective and therefore were not cost-effective. The incremental cost of antibiotic CVCs compared with standard CVCs over a 6-month time horizon was £1160 (95% CI -£4743 to £6962), with an incremental cost-effectiveness ratio of £54,057 per BSI avoided. There was considerable uncertainty in costs: antibiotic CVCs had a probability of 0.35 of being dominant. Based on index hospital stay costs only, antibiotic CVCs were associated with a saving of £97,543 per BSI averted. The estimated value of health-care resources associated with each BSI was £10,975 (95% CI -£2801 to £24,751). Generalisability and cost-impact - the baseline risk of BSI in 2012 for PICUs in England was 4.58 (95% CI 4.42 to 4.74) per 1000 bed-days. An estimated 232 BSIs could have been averted in 2012 using antibiotic CVCs. The additional cost of purchasing antibiotic CVCs for all children who require them (£36 per CVC) would be less than the value of resources associated with managing BSIs in PICUs with standard BSI rates of > 1.2 per 1000 CVC-days.<h4>Conclusions</h4>The primary outcome did not differ between impregnated and standard CVCs. However, antibiotic-impregnated CVCs significantly reduced the risk of BSI compared with standard and heparin CVCs. Adoption of antibiotic-impregnated CVCs could be beneficial even for PICUs with low BSI rates, although uncertainty remains whether or not they represent value for money to the NHS. Limitations - inserting clinicians were not blinded to allocation and a lower than expected event rate meant that there was limited power for head-to-head comparisons of each type of impregnation. Future work - adoption of impregnated CVCs in PICUs should be considered and could be monitored through linkage of electronic health-care data and clinical data on CVC use with laboratory surveillance data on BSI.<h4>Trial registration</h4> NCT01029717.<h4>Funding</h4>This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 18. See the NIHR Journals Library website for further project information.

Item Type: Article
Uncontrolled Keywords: Humans, Rifampin, Minocycline, Heparin, Anti-Bacterial Agents, Adolescent, Child, Child, Preschool, Intensive Care Units, Pediatric, Cost-Benefit Analysis, State Medicine, England, Female, Male, Catheter-Related Infections, Central Venous Catheters
Depositing User: Symplectic Admin
Date Deposited: 25 Apr 2016 13:45
Last Modified: 15 Dec 2022 21:51
DOI: 10.3310/hta20180
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