NCT01713595

Safety Study of Inhaled Saline in Acute Lung Injury

Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pulmonary Edema

Interventions

Type	Name	Description
DRUG	Hypertonic Saline Aerosol	A single 5ml dose of 7% Saline aerosol

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-10-25
• Last updated: 2015-08-17