A Phase 3 interventional study of 2% chlorhexidine digluconate solution with surface-active agents and Usual Baths in Health Care Associated Infection, Ventilator Associated Pneumonia and Central Line-associated Bloodstream Infection (CLABSI), sponsored by Hospital do Coracao. Completed at 16 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by Hospital do Coracao · Phase 3, Interventional, and Prevention
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.
244 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's enrollment of 15,730 is above the median of 204 across 146 interventional studies indexed under Cross Infection.
Browse Cross Infection studies →Hospital do Coracao is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
All patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
Other: 2% chlorhexidine digluconate solution with surface-active agents
All patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
Other: Usual Baths
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.
Also known as: Chlorhexidine baths
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.
Also known as: Soap and water baths
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
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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: 1 year after publication of primary results
Access criteria: Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. Data privacy law.
Ran from Aug 2022 to primary completion in Mar 2024, 19 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Hospital do Coracao