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Completed

NCT Number: NCT02704923

Atropine for Preventing Ventilator-Associated Pneumonia

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

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Key information

Conditions

Ventilator-associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine

Drug

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

Other names: Atropine eye drops

Placebo

Drug

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

Other names: Placebo eye drops

Primary outcomes

  1. Ventilator-Associated Pneumonia

    Time frame: 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 outcomes

  1. Death

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidade de Passo Fundo

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2016
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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