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Safety Study of Inhaled Saline in Acute Lung Injury

This study has been withdrawn prior to enrollment.
(difficult getting subjects)
Information provided by (Responsible Party):
Richard A. Oeckler, M.D., Ph.D., Mayo Clinic Identifier:
First received: October 4, 2012
Last updated: August 14, 2015
Last verified: August 2015
To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).

Condition Intervention Phase
Pulmonary Edema
Drug: Hypertonic Saline Aerosol
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury

Resource links provided by NLM:

Further study details as provided by Richard A. Oeckler, M.D., Ph.D., Mayo Clinic:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: October 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nebulized hypertonic saline

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01713595

Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Richard A Oeckler, M.D., Ph.D. Mayo Clinic
  More Information

Responsible Party: Richard A. Oeckler, M.D., Ph.D., Assistant Professor of Medicine and Physiology, Mayo Clinic Identifier: NCT01713595     History of Changes
Other Study ID Numbers: 12-001723
Study First Received: October 4, 2012
Last Updated: August 14, 2015

Keywords provided by Richard A. Oeckler, M.D., Ph.D., Mayo Clinic:
Acute Lung Injury
Mechanical Ventilation

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Pulmonary Edema
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders processed this record on May 25, 2017