Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury
Status: | Terminated |
---|---|
Conditions: | Hospital, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/10/2019 |
Start Date: | May 2012 |
End Date: | November 6, 2018 |
A Clinical Study to Determine if Nebulized Hypertonic Saline Attenuates Acute Lung Injury Following Trauma and Hemorrhagic Shock
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.
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.
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.
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.
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
We found this trial at
1
site
777 Bannock St
Denver, Colorado 80204
Denver, Colorado 80204
(303) 436-6000
Principal Investigator: Ernest E. Moore, M.D.
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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