TY - JOUR
T1 - Daily chlorhexidine bathing to reduce bacteraemia in critically ill children
T2 - A multicentre, cluster-randomised, crossover trial
AU - Milstone, Aaron M.
AU - Elward, Alexis
AU - Song, Xiaoyan
AU - Zerr, Danielle M.
AU - Orscheln, Rachel
AU - Speck, Kathleen
AU - Obeng, Daniel
AU - Reich, Nicholas G.
AU - Coffin, Susan E.
AU - Perl, Trish M.
N1 - Funding Information:
AMM, TMP, DMZ, SEC, XS, and AE have received grant support from Sage Products. Furthermore, AMM has received grant support from BioMerieux, DMZ has received grant support from Vioguard, TMP has received grant support from Merck and is on an advisory board for Pfizer and Hospira, and XS has received grant support from Optimer Pharmaceuticals. All other authors report no conflicts of interest.
Funding Information:
This study was funded mainly by grants from Sage Products (to AE, XS, DMZ, SEC, and TMP), with additional funding from NIH/NIAID 1 K23 AI081752 (to AMM) and UL1 RR 025005 from the National Center for Research Resources (NCRR), part of the National Institutes of Health (NIH) and NIH Roadmap for Medical Research. This research does not represent the official view of NCRR or NIH. We thank Evan Anderson (Northwestern University), Howard Lederman (Johns Hopkins University), the Johns Hopkins Biostatistics Center, Michael Climo (Medical College of Virginia), the intensive-care nurses at every site, and families and patients for their participation. Data were presented in part at the annual scientific meetings of the Society of Healthcare Epidemiology of America, held in Dallas, TX, USA, April, 2011 (abstract LB-14), and the Infectious Diseases Society of America, held in Boston, MA, USA, October, 2011 (abstract LB-36).
PY - 2013/3/1
Y1 - 2013/3/1
N2 - Background Bacteraemia is an important cause of morbidity and mortality in critically ill children. Our objective was to assess whether daily bathing in chlorhexidine gluconate (CHG) compared with standard bathing practices would reduce bacteraemia in critically ill children. Methods In an unmasked, cluster-randomised, two-period crossover trial, ten paediatric intensive-care units at five hospitals in the USA were randomly assigned a daily bathing routine for admitted patients older than 2 months, either standard bathing practices or using a cloth impregnated with 2% CHG, for a 6-month period. Units switched to the alternative bathing method for a second 6-month period. 6482 admissions were screened for eligibility. The primary outcome was an episode of bacteraemia. We did intention-to-treat (ITT) and per-protocol (PP) analyses. This study is registered with ClinicalTrials.gov (identifier NCT00549393). Findings 1521 admitted patients were excluded because their length of stay was less than 2 days, and 14 refused to participate. 4947 admissions were eligible for analysis. In the ITT population, a non-significant reduction in incidence of bacteraemia was noted with CHG bathing (3·52 per 1000 days, 95% CI 2·64-4·61) compared with standard practices (4·93 per 1000 days, 3·91-6·15; adjusted incidence rate ratio [aIRR] 0·71, 95% CI 0·42-1·20). In the PP population, incidence of bacteraemia was lower in patients receiving CHG bathing (3·28 per 1000 days, 2·27-4·58) compared with standard practices (4·93 per 1000 days, 3·91-6·15; aIRR 0·64, 0·42-0·98). No serious study-related adverse events were recorded, and the incidence of CHG-associated skin reactions was 1·2 per 1000 days (95% CI 0·60-2·02). Interpretation Critically ill children receiving daily CHG bathing had a lower incidence of bacteraemia compared with those receiving a standard bathing routine. Furthermore, the treatment was well tolerated. Funding Sage Products, US National Institutes of Health.
AB - Background Bacteraemia is an important cause of morbidity and mortality in critically ill children. Our objective was to assess whether daily bathing in chlorhexidine gluconate (CHG) compared with standard bathing practices would reduce bacteraemia in critically ill children. Methods In an unmasked, cluster-randomised, two-period crossover trial, ten paediatric intensive-care units at five hospitals in the USA were randomly assigned a daily bathing routine for admitted patients older than 2 months, either standard bathing practices or using a cloth impregnated with 2% CHG, for a 6-month period. Units switched to the alternative bathing method for a second 6-month period. 6482 admissions were screened for eligibility. The primary outcome was an episode of bacteraemia. We did intention-to-treat (ITT) and per-protocol (PP) analyses. This study is registered with ClinicalTrials.gov (identifier NCT00549393). Findings 1521 admitted patients were excluded because their length of stay was less than 2 days, and 14 refused to participate. 4947 admissions were eligible for analysis. In the ITT population, a non-significant reduction in incidence of bacteraemia was noted with CHG bathing (3·52 per 1000 days, 95% CI 2·64-4·61) compared with standard practices (4·93 per 1000 days, 3·91-6·15; adjusted incidence rate ratio [aIRR] 0·71, 95% CI 0·42-1·20). In the PP population, incidence of bacteraemia was lower in patients receiving CHG bathing (3·28 per 1000 days, 2·27-4·58) compared with standard practices (4·93 per 1000 days, 3·91-6·15; aIRR 0·64, 0·42-0·98). No serious study-related adverse events were recorded, and the incidence of CHG-associated skin reactions was 1·2 per 1000 days (95% CI 0·60-2·02). Interpretation Critically ill children receiving daily CHG bathing had a lower incidence of bacteraemia compared with those receiving a standard bathing routine. Furthermore, the treatment was well tolerated. Funding Sage Products, US National Institutes of Health.
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U2 - 10.1016/S0140-6736(12)61687-0
DO - 10.1016/S0140-6736(12)61687-0
M3 - Article
C2 - 23363666
AN - SCOPUS:84875722484
SN - 0140-6736
VL - 381
SP - 1099
EP - 1106
JO - The Lancet
JF - The Lancet
IS - 9872
ER -