NCT02704923

Atropine for Preventing Ventilator-Associated Pneumonia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidade de Passo Fundo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator-Associated Pneumonia

Interventions

Type	Name	Description
DRUG	Atropine	Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
DRUG	Placebo	Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-03-10
• Last updated: 2016-03-10