Daily Chlorexidine Bath for Health Care Associated Infection Prevention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial

Conditions
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Health Care Associated Infection, Ventilator Associated Pneumonia, Central Line-associated Bloodstream Infection (CLABSI), Catheter-Associated Urinary Tract Infection

Intervention / Treatment
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* Other: 2% chlorhexidine digluconate solution with surface-active agents
* Other: Usual Baths


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients ≥ 18 years/old admitted to the participants's ICUs Exclusion Criteria: History of chlorhexidine allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study consists in two intervention (chlorhexidine baths) periods (three months each period) and two control (usual baths) periods (three months each period) for each cluster. The clusters will crossover between intervention and control with one month of washout period between different periods.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine baths<br>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<br>* 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.<br>* Other names: Chlorhexidine baths;|
| Active Comparator: Usual baths<br>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<br>* 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.<br>* Other names: Soap and water baths;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Within each cluster duration (90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of multi-drug-resistant pathogens | Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens. | Within each cluster duration (90 days) | 
| Ventilator associated pneumonia (VAP) | Rates of Ventilator associated pneumonia (VAP) | Within each cluster duration (90 days) | 
| Central line-associated blood stream infections (CLABSI) | Rates of Central line-associated blood stream infections (CLABSI) | Within each cluster duration (90 days) | 
| Catheter-associated urinary tract infection (CAUTI) | Rates of Catheter-associated urinary tract infection (CAUTI) | Within each cluster duration (90 days) | 
| Hospital length of stay | Hospital length of stay | Until hospital discharge, maximum 90 days | 
| Intensive Care Unit length of stay | Intensive Care Unit length of stay | Until Intensive Care Unit discharge, maximum 90 days | 
| Antibiotic use | Antibiotic use per unit | Within each cluster duration (90 days) | 
| In hospital mortality | In hospital mortality | Maximum 90 days after randomization | 
| Intensive Care Unit mortality | Intensive Care Unit mortality | Maximum 90 days after randomization |