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Trial record 15 of 1164 for:    "Acute Lung Injury"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667666
Recruitment Status : Terminated (low enrollment and loss of funding)
First Posted : August 17, 2012
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Ernest E. Moore, MD, Denver Health and Hospital Authority

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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Adult Respiratory Distress Syndrome Drug: Nebulized hypertonic saline Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Clinical Study to Determine if Nebulized Hypertonic Saline Attenuates Acute Lung Injury Following Trauma and Hemorrhagic Shock
Actual Study Start Date : May 2012
Actual Primary Completion Date : November 6, 2018
Actual Study Completion Date : November 6, 2018


Arm Intervention/treatment
Experimental: Nebulized HTS
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.
Drug: Nebulized hypertonic saline
The first 5 patients will receive 3% hypertonic saline in a nebulizer, 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.




Primary Outcome Measures :
  1. change in the respiratory parameters [ Time Frame: baseline and every 6 hours for 36 hours ]
    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.


Secondary Outcome Measures :
  1. death within 28 days [ Time Frame: 28 days or discharge ]
    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.

  2. lung dysfunction scores [ Time Frame: baseline and 28 days or discharge ]
    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.

  3. ventilator-free days (VFD) [ Time Frame: baseline and 28 days or discharge ]
    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.

  4. MOF scores (Denver MOF score) [ Time Frame: 28 days or discharge ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667666


Locations
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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
University of Colorado, Denver
Investigators
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Principal Investigator: Ernest E Moore, MD Denver Health and Hospital Authority
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Responsible Party: Ernest E. Moore, MD, Professor of Surgery, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01667666    
Other Study ID Numbers: COMIRB #11-0706
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Keywords provided by Ernest E. Moore, MD, Denver Health and Hospital Authority:
trauma
acute lung injury
adult respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Distress Syndrome, Newborn
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries