Abstract
Critical Care Science. 2024;36:e20240053en
09-18-2024
DOI 10.62675/2965-2774.20240053-en
Critically ill patients are at increased risk of health care-associated infections due to various devices (central line-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which pose a significant threat to this population. Among several strategies, daily bathing with chlorhexidine digluconate, a water-soluble antiseptic, has been studied as an intervention to decrease the incidence of health care-associated infections in the intensive care unit; however, its ability to reduce all health care-associated infections due to various devices is unclear. We designed the Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) trial to assess whether daily chlorhexidine digluconate bathing reduces the incidence of health care-associated infections in critically ill patients compared with soap and water bathing.
The CLEAN-IT trial is a multicenter, open-label, cluster randomized crossover clinical trial. All adult patients admitted to the participating intensive care units will be included in the trial. Each cluster (intensive care unit) will be randomized to perform either initial chlorhexidine digluconate bathing or soap and water bathing with crossover for a period of 3 to 6 months, depending on the time of each center’s entrance to the study, with a 1-month washout period between chlorhexidine digluconate bathing and soap and water bathing transitions. The primary outcome is the incidence of health care-associated infections due to devices. The secondary outcomes are the incidence of each specific health care-associated infection, rates of microbiological cultures positive for multidrug-resistant pathogens, antibiotic use, intensive care unit and hospital length of stay, and intensive care unit and hospital mortality.
The CLEAN-IT trial will be used to study feasible and affordable interventions that might reduce the health care-associated infection burden in critically ill patients.
Abstract
Revista Brasileira de Terapia Intensiva. 2012;24(4):369-374
01-30-2012
DOI 10.1590/S0103-507X2012000400013
OBJECTIVE: To evaluate the effects of oral chlorhexidine hygiene with toothbrushing on the rate of ventilator-associated pneumonia in a mixed population of critically ill patients under prolonged mechanical ventilation. METHODS: Prospective, randomized, and placebo-controlled pilot study. Patients who were receiving mechanical ventilation, had been admitted less than 24 hours prior, and were anticipated to require mechanical ventilation for more than 72 hours were included in the study. The patients were randomly divided into one of the following groups: chlorhexidine hygiene with toothbrushing or a placebo group (gel with the same color and consistency and toothbrushing). RESULTS: The planned interim analysis was conducted using 52 patients, and the study was terminated prematurely. In total, 28 patients were included in the chlorhexidine / toothbrushing group, and 24 patients were included in the placebo group. Ventilator-associated pneumonia occurred in 45.8% of the placebo group and in 64.3% of the chlorhexidine hygiene with toothbrushing group (RR=1.4; 95% CI=0.83-2.34; p=0.29). CONCLUSION: Because the study was terminated due to futility, it was not possible to evaluate the impact of oral hygiene using 2% chlorhexidine and toothbrushing on the incidence of ventilator-associated pneumonia in this heterogeneous population of critical patients receiving long-term mechanical ventilation, and no beneficial effect was observed for this intervention.