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Safety Study of Inhaled Saline in Acute Lung Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Richard A. Oeckler, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01713595
First received: October 4, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    "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 ] [ Designated as safety issue: Yes ]
    Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.


Estimated Enrollment: 15
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713595

Contacts
Contact: Richard A Oeckler, M.D., Ph.D. 507-284-2158 oeckler.richard@mayo.edu
Contact: Steven Holets, RRT 507 256 8718 holets.steven@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Richard A Oeckler, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Richard A Oeckler, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Richard A. Oeckler, M.D., Ph.D., Assistant Professor of Medicine and Physiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01713595     History of Changes
Other Study ID Numbers: 12-001723
Study First Received: October 4, 2012
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Acute Lung Injury
Mechanical Ventilation

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Pulmonary Edema
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014