Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury

Denver Health and Hospital Authority

Status and phase: Terminated; Phase 1

Conditions: Adult Respiratory Distress Syndrome; Acute Lung Injury

Treatments: Drug: Nebulized hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01667666

COMIRB #11-0706

Details and patient eligibility

About

This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.

Full description

Despite over 40 years of investigation, acute lung injury (ALI) remains a leading cause of morbidity in critically ill patients, and a disease for which there is no effective pharmacologic therapy. Our group and others have focused on the anti-inflammatory effects of intravenous hypertonic saline (HTS) acting on the injured endothelium with promising results experimentally, but failed to confirm the benefit clinically. Recent work, however, has shown that inhaled or nebulized HTS targeted at the epithelium is safe and effective in treating cystic fibrosis, COPD, and neonatal bronchiolitis. Recognizing the central role of the pulmonary epithelium in ALI, nebulization has the advantage of achieving high concentrations of the therapy without producing systemic side effects. Thus, we hypothesize that nebulized hypertonic saline will attenuate acute lung injury following trauma.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult 18 ≤ age ≤ 65
• trauma with a 9 ≤ NISS ≤ 36
• ≤10 units of RBC in the first 6 hours (as this is a major risk factor for ARDS and MOF in this population)

Exclusion criteria

• Direct or indirect lung injury
• Elevated intracranial pressure requiring treatment, including but not limited to mannitol, intravenous hypertonic saline, and ventricular drainage
• History of severe chronic respiratory disease
• Child-Pugh Class C liver failure
• Prisoners
• Pregnant women

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Nebulized HTS

Experimental group

Description:

The first 5 patients will receive 3% Nebulized hypertonic saline, the second 5 patients will receive 4.5% Nebulized hypertonic saline, the third group 6% Nebulized hypertonic saline, and the fourth group of 5 patients will receive 7% Nebulized hypertonic saline. The nebulizer is dosed 2-3 times a day for 36 hours.

Treatment:

Drug: Nebulized hypertonic saline