Scrubbing children in intensive care units with chlorhexidine daily cut the incidence of bacteremia by more than 35% in a randomized, crossover trial, researchers said.
On a per-protocol basis, the incidence of bacteremia in pediatric ICUs using the daily chlorhexidine baths was 3.28 per 1,000 patient-days, compared with 4.93 per 1,000 patient-days with standard bathing practices (adjusted incidence ratio 0.64, 95% CI 0.42 to 0.98), reported Aaron Milstone, MD, of Johns Hopkins University, and colleagues online inThe Lancet.
The benefit was less clear in a larger intent-to-treat analysis, however. There, the aIR for bacteremia was 0.71 (95% CI 0.42 to 1.20) for the intervention relative to standard practice.
Despite this difference, Milstone and colleagues declared the intervention a success. “We have shown that a simple and easily implementable intervention decreased bacteremia in critically ill children,” they wrote.
Want to publish your own articles on DistilINFO Publications?
Send us an email, we will get in touch with you.
“Broad use of this intervention could reduce morbidity and costs from bacteremia in this vulnerable and understudied population,” they added.
The study involved ten pediatric ICUs in U.S. hospitals. It used a cluster-randomized crossover design in which, rather than assigning individual patients to the intervention or a control, the unit of randomization was the ICU.
Thus, each center was randomized initially to perform the intervention or control on all admitted children for 6 months and then, after a 2-week “washout” period, to switch over to the other hygiene method. Milstone and colleagues also took steps to insure that ICU types (surgical versus cardiac and medical) were balanced appropriately.
Control in the study was a daily bath with plain soap and water or daily full-body wipedown with Comfort Bath, a non-antiseptic prepackaged moist washcloth.
The intervention was a daily wipedown with an investigational washcloth impregnated with 2% chlorhexidine gluconate. Both this product and Comfort Bath were supplied by Sage Products, which cosponsored the study.
The study cohort had a total of 4,947 patients with 2,525 assigned to control and 2,422 to the intervention.
For the control patients, the intent-to-treat and per-protocol populations were the same. However, consent for participation could not be obtained for about one-third of patients in the ICUs assigned to the intervention. Outcomes in those patients were included in the intent-to-treat analysis but not in the per-protocol analysis.
The study design precluded blinding of healthcare providers or patients’ caregivers to the treatment assignments, Milstone and colleagues noted.
In the per-protocol population, a total of 113 cases of bacteremia in 103 individual patients were diagnosed. Of these, 34 cases occurred with the chlorhexidine bathing whereas 79 occurred with standard practice.
Milstone and colleagues indicated that all but 12 of the cases occurred in patients with central venous catheters. “Of this group, those who were bathed with [chlorhexidine] had a 34% lower risk of bacteremia,” they wrote, with an aIR of 0.66 (95% CI 0.47 to 0.94).
The per-protocol data, without adjustment for other factors, also indicated a trend toward reduced mortality with the intervention (2.59% versus 3.49%, P=0.11).
Most of these differences were substantially attenuated in the intent-to-treat analysis, in which many children admitted to units performing the intervention received the control treatment, because consent to the protocol was not obtained.
One exception, however, was the risk of bacteremia in patients with central venous catheters. In this group, the aIR with the intervention was 0.65 (95% CI 0.44 to 0.97), virtually identical to the per-protocol finding.
No serious study-related adverse events were recorded, and the incidence of chlorhexidine-associated skin reactions was 1.2 per 1,000 days (95% CI 0.60 to 2.02).
Limitations to the study included its focus on bacteremia and mortality as outcomes, the large number of potential participants for whom consent could not be obtained, differences between centers in IRB-mandated processes for informing caregivers, and lack of data on important patient factors that may have affected bacteremia risk.
Also, diagnoses of bacteremia were made at participating centers without review or adjudication by a central committee.