Atropine for Preventing Ventilator-Associated Pneumonia

March 9, 2016 updated by: Cassiano Mateus Forcelini, Universidade de Passo Fundo
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
ACTIVE_COMPARATOR: Atropine
Drug: Atropine
Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
Other Names:
  • Atropine eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through the end of the study, an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through the end of the study, an average of one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through the end of the study, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade de Passo Fundo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (ESTIMATE)

March 10, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 40374815.3.0000.5342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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