Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.
Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
15,730
Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.
Bathing will be performed at least daily using soap and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.
Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina
Colatina, Espírito Santo, Brazil
Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Composite of healthcare-associated infections (HAI)
Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)
Time frame: Within each cluster duration (90 days)
Rates of multi-drug-resistant pathogens
Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.
Time frame: Within each cluster duration (90 days)
Ventilator associated pneumonia (VAP)
Rates of Ventilator associated pneumonia (VAP)
Time frame: Within each cluster duration (90 days)
Central line-associated blood stream infections (CLABSI)
Rates of Central line-associated blood stream infections (CLABSI)
Time frame: Within each cluster duration (90 days)
Catheter-associated urinary tract infection (CAUTI)
Rates of Catheter-associated urinary tract infection (CAUTI)
Time frame: Within each cluster duration (90 days)
Hospital length of stay
Hospital length of stay
Time frame: Until hospital discharge, maximum 90 days
Intensive Care Unit length of stay
Intensive Care Unit length of stay
Time frame: Until Intensive Care Unit discharge, maximum 90 days
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Hospital da Cidade
Salvador, Estado de Bahia, Brazil
Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Hospital Municipal de Maringá
Maringá, Paraná, Brazil
Hospital Regional do Baixo Amazonas Dr. Waldemar Penna
Santarém, Pará, Brazil
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Santa Cruz
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
...and 6 more locations
Antibiotic use
Antibiotic use per unit
Time frame: Within each cluster duration (90 days)
In hospital mortality
In hospital mortality
Time frame: Maximum 90 days after randomization
Intensive Care Unit mortality
Intensive Care Unit mortality
Time frame: Maximum 90 days after randomization