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2016 ; 20
(18
): vii-xxviii, 1-219
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English Wikipedia
CATheter Infections in CHildren (CATCH): a randomised controlled trial and
economic evaluation comparing impregnated and standard central venous catheters
in children
#MMPMID26935961
Harron K
; Mok Q
; Dwan K
; Ridyard CH
; Moitt T
; Millar M
; Ramnarayan P
; Tibby SM
; Muller-Pebody B
; Hughes DA
; Gamble C
; Gilbert RE
Health Technol Assess
2016[Mar]; 20
(18
): vii-xxviii, 1-219
PMID26935961
show ga
BACKGROUND: Impregnated central venous catheters (CVCs) are recommended for
adults to reduce bloodstream infection (BSI) but not for children. OBJECTIVE: To
determine the effectiveness of impregnated compared with standard CVCs for
reducing BSI in children admitted for intensive care. DESIGN: Multicentre
randomised controlled trial, cost-effectiveness analysis from a NHS perspective
and a generalisability analysis and cost impact analysis. SETTING: 14 English
paediatric intensive care units (PICUs) in England. PARTICIPANTS: Children aged
16 years admitted to a PICU and expected to require a CVC for ??3 days.
INTERVENTIONS: 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. MAIN OUTCOME MEASURE:
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. RESULTS: 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. CONCLUSIONS: 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. TRIAL
REGISTRATION: ClinicalTrials.gov NCT01029717. FUNDING: 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.