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Safety Study of Inhaled Saline in Acute Lung Injury

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Mayo Clinic

Status and phase

Withdrawn
Phase 1

Conditions

Pulmonary Edema

Treatments

Drug: Hypertonic Saline Aerosol

Study type

Interventional

Funder types

Other

Identifiers

NCT01713595
12-001723

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 ARDS.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Hypertonic Saline Aerosol
Experimental group
Description:
a single 5ml dose of 7% Saline aerosol
Treatment:
Drug: Hypertonic Saline Aerosol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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