Catheter-Associated Urinary Tract Infection, Central Line-associated Bloodstream Infection (CLABSI), Health Care Associated Infection, Ventilator Associated Pneumonia
Conditions
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.
Interventions
OTHER2% chlorhexidine digluconate solution with surface-active agents
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.
OTHERUsual Baths
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.
Sponsors
Hospital Sírio-Libanês
Hospital Israelita Albert Einstein
Hospital Moinhos de Vento
Hospital Alemão Oswaldo Cruz
A Beneficência Portuguesa de São Paulo
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients ≥ 18 years/old admitted to the participants's ICUs
Exclusion criteria
* History of chlorhexidine allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| In hospital mortality | Maximum 90 days after randomization | In hospital mortality |
| Intensive Care Unit mortality | Maximum 90 days after randomization | Intensive Care Unit mortality |
| Intensive Care Unit length of stay | Until Intensive Care Unit discharge, maximum 90 days | Intensive Care Unit length of stay |
Countries
Brazil
Outcome results
None listed