Safety Study of Inhaled Saline in Acute Lung Injury
This study is currently recruiting participants.
Verified October 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Rolf D. Hubmayr, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01713595
First received: October 4, 2012
Last updated: October 24, 2012
Last verified: October 2012
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Purpose
To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute lung injury [ALI].
| 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: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (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
|
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 ALI 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 ALI.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713595
Contacts
| Contact: Rolf D Hubmayr, MD | 507 255 9814 | rhubmayr@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: Rolf D Hubmayr, MD | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Rolf Hubmayr, MD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Rolf D. Hubmayr, Professor od 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: | October 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Acute Lung Injury Mechanical Ventilation |
Additional relevant MeSH terms:
|
Edema Pulmonary Edema Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Signs and Symptoms |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013