Daily Chlorexidine Bath for Health Care Associated Infection Prevention

Phase 3

Completed

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

• Registration Number: NCT05485051
• Lead Sponsor: Hospital do Coracao

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-31
• Study First Posted: 2022-08-02
• Study Start: 2022-08-03
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15730

Inclusion Criteria

• All patients ≥ 18 years/old admitted to the participants's ICUs

Exclusion Criteria

• History of chlorhexidine allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Composite of healthcare-associated infections (HAI)	Within each cluster duration (90 days)	Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Hospital da Bahia; 🇧🇷 Salvador, BA, Brazil

Hospital da Cidade; 🇧🇷 Salvador, BA, Brazil

Hospital Universitário de Brasília; 🇧🇷 Brasília, DF, Brazil

Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina; 🇧🇷 Colatina, ES, Brazil

Hospital Regional do Baixo Amazonas Dr. Waldemar Penna; 🇧🇷 Santarém, PA, Brazil

Hospital das Clínicas da Universidade Federal de Pernambuco; 🇧🇷 Recife, PE, Brazil

Hospital Municipal de Maringá; 🇧🇷 Maringá, PR, Brazil

Hospital Geral de Caxias do Sul; 🇧🇷 Caxias do Sul, RS, Brazil

Hospital Santa Cruz; 🇧🇷 Santa Cruz do Sul, RS, Brazil

Hospital Nereu Ramos; 🇧🇷 Florianópolis, Sc, Brazil

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