Clinical trial NCT05485051: Daily Chlorexidine Bath for Health Care Associated Infection Prevention
Official title: Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Health Care Associated Infection
Ventilator Associated Pneumonia
Central Line-associated Bloodstream Infection (CLABSI)
Catheter-Associated Urinary Tract Infection
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Hospital Sírio-Libanês
name: Hospital Israelita Albert Einstein
name: Hospital Moinhos de Vento
name: Hospital Alemão Oswaldo Cruz
name: A Beneficência Portuguesa de São Paulo
First posted: 2022-08-02
Enrollment: 15730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* History of chlorhexidine allergy

Primary outcomes:
measure: Composite of healthcare-associated infections (HAI)
timeFrame: Within each cluster duration (90 days)
Secondary outcomes:
measure: Rates of multi-drug-resistant pathogens
timeFrame: Within each cluster duration (90 days)
measure: Ventilator associated pneumonia (VAP)
timeFrame: Within each cluster duration (90 days)
measure: Central line-associated blood stream infections (CLABSI)
timeFrame: Within each cluster duration (90 days)
measure: Catheter-associated urinary tract infection (CAUTI)
timeFrame: Within each cluster duration (90 days)
measure: Hospital length of stay
timeFrame: Until hospital discharge, maximum 90 days
measure: Intensive Care Unit length of stay
timeFrame: Until Intensive Care Unit discharge, maximum 90 days
measure: Antibiotic use
timeFrame: Within each cluster duration (90 days)
measure: In hospital mortality
timeFrame: Maximum 90 days after randomization
measure: Intensive Care Unit mortality
timeFrame: Maximum 90 days after randomization
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital da Bahia
state: BA
city: Salvador
country: Brazil
facility: Hospital da Cidade
state: BA
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília
state: DF
city: Colatina
country: Brazil
facility: Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina
state: ES
city: Santarém
country: Brazil
facility: Hospital Regional do Baixo Amazonas Dr. Waldemar Penna
state: PA
city: Recife
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Pernambuco
state: PE
city: Maringá
country: Brazil
facility: Hospital Municipal de Maringá
state: PR
city: Caxias do Sul
country: Brazil
facility: Hospital Geral de Caxias do Sul
state: RS
city: Santa Cruz do Sul
country: Brazil
facility: Hospital Santa Cruz
state: RS
city: Florianópolis
country: Brazil
facility: Hospital Nereu Ramos
state: Sc
city: Florianópolis
country: Brazil
facility: Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
state: SC
city: Aracaju
country: Brazil
facility: Hospital São Lucas
state: SE
city: São Paulo
country: Brazil
facility: Hospital Aviccena
state: SP
city: Rio De Janeiro
country: Brazil
facility: Hospital Naval Marcílio Dias
city: São Paulo
country: Brazil
facility: AC Camargo Câncer Center
city: São Paulo
country: Brazil
facility: BP-A Beneficiência Portuguesa de São Paulo
Study officials:
affiliation: btomazini@hcor.com.br
name: Bruno M Tomazini, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: HCor Research Institute Director
name: Alexandre B Cavalcanti, M.D
role: STUDY_DIRECTOR
References: