Atropine for Preventing Ventilator-Associated Pneumonia

Sponsor

Universidade de Passo Fundo (Other)

Overall Status

Completed

CT.gov ID

NCT02704923

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ventilator-Associated Pneumonia	Drug: Atropine Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Atropine for Preventing Ventilator-Associated Pneumonia

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atropine	Drug: Atropine Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours Other Names: Atropine eye drops
Placebo Comparator: Placebo	Drug: Placebo Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours Other Names: Placebo eye drops

Arm

Intervention/Treatment

Active Comparator: Atropine

Drug: Atropine

Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours

Other Names:

Atropine eye drops

Placebo Comparator: Placebo

Drug: Placebo

Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours

Other Names:

Placebo eye drops

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Adverse events [through the end of the study, an average of one year]
Incidence of adverse events through the end of the study, an average of one year