Acute Lung Injury Clinical Trial
Official title:
A Clinical Study to Determine if Nebulized Hypertonic Saline Attenuates Acute Lung Injury Following Trauma and Hemorrhagic Shock
Verified date | January 2019 |
Source | Denver Health and Hospital Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | November 6, 2018 |
Est. primary completion date | November 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health Medical Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority | University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in the respiratory parameters | For intubated patients - A decrease greater than 20% in PaO2/FiO2 (P/F) ratios will trigger DSMB review. For not intubated patients - a) the need to increase FiO2 by 10% (approximate 4 liter/minute increase) to maintain a peripheral oxygen saturation (SaO2) of 90% during nebulizer treatment; b) evidence of respiratory distress (as documented in the chart by the patient's attending) during nebulizer treatment; and c) respiratory insufficiency requiring intubation and mechanical ventilation at any point will trigger DSMB review. | baseline and every 6 hours for 36 hours | |
Secondary | death within 28 days | If the rate of death within 28 days for this patient population is less than 50% the expected rate for every 5 patients based on our clinical trauma database over the past 5 years, a DSMB review will be triggered. | 28 days or discharge | |
Secondary | lung dysfunction scores | Denver lung MOF score will be measure daily until discharge or 28 days, which ever is first. For every 5 patients, if the rate of lung dysfunction for this patient population is less than 50% the expected rate based on our clinical trauma database over the past 5 years, a DSMB review will be triggered. | baseline and 28 days or discharge | |
Secondary | ventilator-free days (VFD) | Ventilator free days will be tracked with 28 days as a reference. If the number of VFDs for this patient population is greater than one standard deviation of the predicted value for every 5 patients based on our clinical trauma database over the past 5 years, a DSMB review will be triggered. | baseline and 28 days or discharge | |
Secondary | MOF scores (Denver MOF score) | Denver MOF score will be recorded daily until discharge or 28 days, which ever is sooner. for every 5 patients, if the rate of MOF for this patient population is greater than one standard deviation of the predicted value for every 5 patients based on our clinical trauma database over the past 5 years, a DSMB review will be triggered | 28 days or discharge |
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