Atropine for Preventing Ventilator-Associated Pneumonia

Phase 2

Completed

• Conditions: Ventilator-Associated Pneumonia
• Interventions: Drug: Atropine; Drug: Placebo

• Registration Number: NCT02704923
• Lead Sponsor: Universidade de Passo Fundo

Brief Summary

A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.

Detailed Description

A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-02-26
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours

Exclusion Criteria

• Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine	Atropine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Ventilator-Associated Pneumonia	through the end of the study, an average of one year	Incidence of ventilator-associated pneumonia through the end of the study, an average of one year

Secondary Outcome Measures

Name	Time	Method
Death	through the end of the study, an average of one year	Incidence of death through the end of the study, an average of one year