Safety Study of Inhaled Saline in Acute Lung Injury

August 14, 2015 updated by: Richard A. Oeckler, M.D., Ph.D., Mayo Clinic

Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury

To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

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:

  • 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.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypertonic Saline Aerosol
a single 5ml dose of 7% Saline aerosol
Drug: Hypertonic Saline Aerosol
A single 5ml dose of 7% Saline aerosol
Other Names:
  • Nebulized hypertonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Compliance of the Respiratory System
Time Frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
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
Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Ventilator Interactions
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
"Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy
5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Blood Gas Tension
Time Frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.
Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Richard A Oeckler, M.D., Ph.D., Mayo Clinic

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

October 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-001723

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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