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Atropine for Preventing Ventilator-Associated Pneumonia

Primary Purpose

Ventilator-Associated Pneumonia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atropine
Placebo
Sponsored by
Universidade de Passo Fundo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-Associated Pneumonia focused on measuring Atropine, Pneumonia, Ventilator, Adults, Intensive care unit.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Atropine

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 26, 2016
    Last Updated
    March 9, 2016
    Sponsor
    Universidade de Passo Fundo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02704923
    Brief Title
    Atropine for Preventing Ventilator-Associated Pneumonia
    Official Title
    Atropine for Preventing Ventilator-Associated Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade de Passo Fundo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator-Associated Pneumonia
    Keywords
    Atropine, Pneumonia, Ventilator, Adults, Intensive care unit.

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atropine
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Atropine
    Other Intervention Name(s)
    Atropine eye drops
    Intervention Description
    Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo eye drops
    Intervention Description
    Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours
    Primary Outcome Measure Information:
    Title
    Ventilator-Associated Pneumonia
    Description
    Incidence of ventilator-associated pneumonia through the end of the study, an average of one year
    Time Frame
    through the end of the study, an average of one year
    Secondary Outcome Measure Information:
    Title
    Death
    Description
    Incidence of death through the end of the study, an average of one year
    Time Frame
    through the end of the study, an average of one year
    Other Pre-specified Outcome Measures:
    Title
    Adverse events
    Description
    Incidence of adverse events through the end of the study, an average of one year
    Time Frame
    through the end of the study, an average of one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Atropine for Preventing Ventilator-Associated Pneumonia

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