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Safety Study of Inhaled Saline in Acute Lung Injury

Primary Purpose

Pulmonary Edema

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hypertonic Saline Aerosol
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Edema focused on measuring Acute Lung Injury, Mechanical Ventilation

Eligibility Criteria

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

Inclusion Criteria:

  • Study participants will include consenting adult patients (age > 18), who had been intubated and mechanically ventilated for <72 hours and meet international consensus criteria for ARDS.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hypertonic Saline Aerosol

    Arm Description

    a single 5ml dose of 7% Saline aerosol

    Outcomes

    Primary Outcome Measures

    Dynamic Compliance of the Respiratory System
    Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema

    Secondary Outcome Measures

    Patient-Ventilator Interactions
    "Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy

    Full Information

    First Posted
    October 4, 2012
    Last Updated
    August 14, 2015
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01713595
    Brief Title
    Safety Study of Inhaled Saline in Acute Lung Injury
    Official Title
    Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    difficult getting subjects
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).
    Detailed Description
    Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ARDS center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Edema
    Keywords
    Acute Lung Injury, Mechanical Ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypertonic Saline Aerosol
    Arm Type
    Experimental
    Arm Description
    a single 5ml dose of 7% Saline aerosol
    Intervention Type
    Drug
    Intervention Name(s)
    Hypertonic Saline Aerosol
    Other Intervention Name(s)
    Nebulized hypertonic saline
    Intervention Description
    A single 5ml dose of 7% Saline aerosol
    Primary Outcome Measure Information:
    Title
    Dynamic Compliance of the Respiratory System
    Description
    Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema
    Time Frame
    Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
    Secondary Outcome Measure Information:
    Title
    Patient-Ventilator Interactions
    Description
    "Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy
    Time Frame
    5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery
    Other Pre-specified Outcome Measures:
    Title
    Arterial Blood Gas Tension
    Description
    Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.
    Time Frame
    Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Study participants will include consenting adult patients (age > 18), who had been intubated and mechanically ventilated for <72 hours and meet international consensus criteria for ARDS.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard A Oeckler, M.D., Ph.D.
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety Study of Inhaled Saline in Acute Lung Injury

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