Safety Study of Inhaled Saline in Acute Lung Injury

Phase 1

Withdrawn

• Conditions: Pulmonary Edema
• Interventions: Drug: Hypertonic Saline Aerosol

• Registration Number: NCT01713595
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-25
• Study Start: 2013-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypertonic Saline Aerosol	Hypertonic Saline Aerosol	a single 5ml dose of 7% Saline aerosol

Primary Outcome Measures

Name	Time	Method
Dynamic Compliance of the Respiratory System	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

Name	Time	Method
Patient-Ventilator Interactions	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