Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial

Abstract

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.

Conflict of interest statement

Conflict of Interest Statement: Drs. Milstone, Perl, Zerr, Coffin, Song, Elward received grant support from Sage Products, Inc.. Dr. Milstone has received grant support from BioMerieux Inc.. Dr. Zerr has received grant support from Vioguard, Ltd. Dr. Perl has received grant support from Merck and is on an advisory board for Pfizer and Hospira. Dr. Song has received grant support from Optimer Pharmaceuticals. No other authors reported any conflicts.

Copyright © 2013 Elsevier Ltd. All rights reserved.

Figures

Figure 1

Study profile. Ten intensive care units were randomized to either CHG bathing or standard bathing practices during the First Period and switched to the alternative bathing procedure during Period 2.

Figure 2

Change in crude incidence of bacteremia and CLABSI for per protocol population. Each line represents one unit and the slope of the line represents the change in incidence of bacteremia or CLABSI observed between control and treatment periods. Arrows represent the assignment change from period 1 to period 2 (e.g. an arrow pointing to CHG side of the graph implies that the unit in question was assigned to the CHG arm in Period 2 and the control arm in Period 1 – the assignment started as control and moved to CHG). The thick line represents the overall crude incidence rates comparing the control and CHG units. Units are identified for easy reference to supplemental table 7.