Clinical trial NCT01667666: Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury
Official title: A Clinical Study to Determine if Nebulized Hypertonic Saline Attenuates Acute Lung Injury Following Trauma and Hemorrhagic Shock
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Lung Injury
Adult Respiratory Distress Syndrome
Keywords: trauma
acute lung injury
adult respiratory distress syndrome
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2012-08-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in the respiratory parameters
timeFrame: baseline and every 6 hours for 36 hours
Secondary outcomes:
measure: death within 28 days
timeFrame: 28 days or discharge
measure: lung dysfunction scores
timeFrame: baseline and 28 days or discharge
measure: ventilator-free days (VFD)
timeFrame: baseline and 28 days or discharge
measure: MOF scores (Denver MOF score)
timeFrame: 28 days or discharge
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Ernest E Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: