Ventilator Associated Pneumonia Clinical Trial
— CLEAN-ITOfficial title:
Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial
Verified date | May 2024 |
Source | Hospital do Coracao |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15730 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients = 18 years/old admitted to the participants's ICUs Exclusion Criteria: - History of chlorhexidine allergy |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital São Lucas | Aracaju | SE |
Brazil | Hospital Universitário de Brasília | Brasília | DF |
Brazil | Hospital Geral de Caxias do Sul | Caxias do Sul | RS |
Brazil | Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina | Colatina | ES |
Brazil | Hospital Nereu Ramos | Florianópolis | Sc |
Brazil | Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck | Florianópolis | SC |
Brazil | Hospital Municipal de Maringá | Maringá | PR |
Brazil | Hospital das Clínicas da Universidade Federal de Pernambuco | Recife | PE |
Brazil | Hospital Naval Marcílio Dias | Rio De Janeiro | |
Brazil | Hospital da Bahia | Salvador | BA |
Brazil | Hospital da Cidade | Salvador | BA |
Brazil | Hospital Santa Cruz | Santa Cruz do Sul | RS |
Brazil | Hospital Regional do Baixo Amazonas Dr. Waldemar Penna | Santarém | PA |
Brazil | AC Camargo Câncer Center | São Paulo | |
Brazil | BP-A Beneficiência Portuguesa de São Paulo | São Paulo | |
Brazil | Hospital Aviccena | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital do Coracao | A Beneficência Portuguesa de São Paulo, Hospital Alemão Oswaldo Cruz, Hospital Israelita Albert Einstein, Hospital Moinhos de Vento, Hospital Sírio-Libanês |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | Ventilator associated pneumonia (VAP) | Rates of Ventilator associated pneumonia (VAP) | Within each cluster duration (90 days) | |
Secondary | Central line-associated blood stream infections (CLABSI) | Rates of Central line-associated blood stream infections (CLABSI) | Within each cluster duration (90 days) | |
Secondary | Catheter-associated urinary tract infection (CAUTI) | Rates of Catheter-associated urinary tract infection (CAUTI) | Within each cluster duration (90 days) | |
Secondary | Hospital length of stay | Hospital length of stay | Until hospital discharge, maximum 90 days | |
Secondary | Intensive Care Unit length of stay | Intensive Care Unit length of stay | Until Intensive Care Unit discharge, maximum 90 days | |
Secondary | Antibiotic use | Antibiotic use per unit | Within each cluster duration (90 days) | |
Secondary | In hospital mortality | In hospital mortality | Maximum 90 days after randomization | |
Secondary | Intensive Care Unit mortality | Intensive Care Unit mortality | Maximum 90 days after randomization |
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