The Prevention of Primary Endogenous Ventilator-Associated Pneumonia: A Multicenter Randomized Trial Comparing Continuous Aspiration of Subglottic Content and a 3-Day Course of Ceftriaxone.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pneumonia
- Sponsor
- Hospital Universitario Principe de Asturias
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Cumulative incidence of early-onset ventilator-associated pneumonia
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief Summary
The primary purpose of the trial is to compare the efficacy and safety of two measures which claim to prevent early-onset ventilator-associated pneumonia.
Detailed Description
Background: In a previous double-blind, placebo-controlled, randomized trial we found that a 3-day-course of ceftriaxone significantly reduced the incidence of early-onset ventilator-associated pneumonia (EOP). Continuous aspiration of secretions accumulating in the subglottic space above the cuff of the endotracheal tube has also been shown to prevent EOP. Objective: To compare the effect of both preventive measures on the incidence of EOP. Design: Randomized, multicenter. Setting: Three general intensive care units at university hospitals in Spain. Patients: Patients without signs of infection and no concomitant systemic antibiotics were included if expected to require endotracheal intubation exceeding 2 days. Intervention: All patients were intubated with an endotracheal tube equipped with a port for aspiration of subglottic secretions and subsequently randomized to receive a three day course of 2 gram/day iv ceftriaxone without aspiration of subglottic secretions or continuous aspiration of subglottic secretions. Measurements: All ICU-acquired infections, antibiotic therapy, colonization and infection with 3rd-generation cephalosporin-resistant microorganisms, duration of intubation and ICU-stay and-mortality.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Endotracheal intubation with endotracheal tube equipped with port for aspirations of subglottic contents and expected to exceed 48 hors.
- •Absence of infection.
- •18 years or older.
- •Informed Consent.
Exclusion Criteria
- •Endotracheal intubation prior to admission to hospital.
- •Allergic to beta-lactam antibiotics.
- •Formal indication for systemic antibiotic therapy.
Outcomes
Primary Outcomes
Cumulative incidence of early-onset ventilator-associated pneumonia
Secondary Outcomes
- Duration of intubation and ICU-stay.
- ICU-Mortality.
- All ICU-acquired infections.
- Duration of antibiotic therapy.
- Third-generation cephalosporin resistance.