Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%

Universidad de Guanajuato

Status and phase: Unknown; Phase 3

Conditions: Ventilator Associated Pneumonia; Chlorhexidine

Treatments: Drug: Chlorhexidine gluconate at 0.12%; Drug: Chlorhexidine gluconate at 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT03442023

SSGTO00153

Details and patient eligibility

About

This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-desirable condition that leads to higher mortality rates and longer hospitalization times. One group will receive the 0.12% chlorhexidine mouthwash and the other group will receive the 2% chlorhexidine mouthwash.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with minimum required age of consent that were admitted to the intensive care unit and who received at least 48 hours of mechanical ventilation.

Exclusion criteria

• Patients who wish to withdraw consent and leave the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

Chlorhexidine 2%

Experimental group

Description:

Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 2% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 2%

Treatment:

Drug: Chlorhexidine gluconate at 2%

Chlorhexidine 0.12%

Active Comparator group

Description:

Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 0.12% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 0.12%

Treatment:

Drug: Chlorhexidine gluconate at 0.12%