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
• Interventions: Other: 2% chlorhexidine digluconate solution with surface-active agents; Other: Usual Baths

• 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

Arm && Interventions

Group	Intervention	Description
Chlorhexidine baths	2% chlorhexidine digluconate solution with surface-active agents	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.
Usual baths	Usual Baths	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.

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
Antibiotic use	Within each cluster duration (90 days)	Antibiotic use per unit
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.
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 Maternidade São José - UNESC - Fundação Social Rural de Colatina; 🇧🇷 Colatina, ES, Brazil

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

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

AC Camargo Câncer Center; 🇧🇷 São Paulo, Brazil

Hospital Aviccena; 🇧🇷 São Paulo, SP, Brazil

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

Hospital da Cidade; 🇧🇷 Salvador, BA, Brazil

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

Hospital Nereu Ramos; 🇧🇷 Florianópolis, Sc, Brazil

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

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

Hospital São Lucas; 🇧🇷 Aracaju, SE, Brazil

Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck; 🇧🇷 Florianópolis, SC, Brazil

Hospital Naval Marcílio Dias; 🇧🇷 Rio De Janeiro, Brazil

BP-A Beneficiência Portuguesa de São Paulo; 🇧🇷 São Paulo, Brazil