Safety Study of Inhaled Saline in Acute Lung Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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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

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Pulmonary Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypertonic Saline Aerosol

a single 5ml dose of 7% Saline aerosol

Group Type EXPERIMENTAL

Hypertonic Saline Aerosol

Intervention Type DRUG

A single 5ml dose of 7% Saline aerosol

Interventions

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Hypertonic Saline Aerosol

A single 5ml dose of 7% Saline aerosol

Intervention Type DRUG

Other Intervention Names

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Nebulized hypertonic saline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No