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

October 4, 2012
May 1, 2014
October 2012
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01713595 on ClinicalTrials.gov Archive Site
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
Same as current
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.
Same as current
 
Safety Study of Inhaled Saline in Acute Lung Injury
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).

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Edema
Drug: Hypertonic Saline Aerosol
A single 5ml dose of 7% Saline aerosol
Other Name: Nebulized hypertonic saline
Experimental: Hypertonic Saline Aerosol
a single 5ml dose of 7% Saline aerosol
Intervention: Drug: Hypertonic Saline Aerosol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
United States
 
NCT01713595
12-001723
No
Richard A. Oeckler, M.D., Ph.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Richard A Oeckler, M.D., Ph.D. Mayo Clinic
Mayo Clinic
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP