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Trial record 15 of 1188 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

Tracking Information
First Submitted Date  ICMJE August 10, 2012
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date November 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
change in the PaO2/FiO2 (P/F) ratios [ Time Frame: baseline and every 6 hours for 36 hours ]
A decrease greater than 20% will trigger DSMB review
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • 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.
  • lung dysfunction scores [ Time Frame: 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.
  • ventilator-free days (VFD) [ Time Frame: 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury
Official Title  ICMJE A Clinical Study to Determine if Nebulized Hypertonic Saline Attenuates Acute Lung Injury Following Trauma and Hemorrhagic Shock
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Lung Injury
  • Adult Respiratory Distress Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Nebulized hypertonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 15, 2018)
13
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2012)
20
Actual Study Completion Date  ICMJE November 6, 2018
Actual Primary Completion Date November 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01667666
Other Study ID Numbers  ICMJE COMIRB #11-0706
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ernest E. Moore, MD, Denver Health and Hospital Authority
Study Sponsor  ICMJE Denver Health and Hospital Authority
Collaborators  ICMJE University of Colorado, Denver
Investigators  ICMJE
Principal Investigator: Ernest E Moore, MD Denver Health and Hospital Authority
PRS Account Denver Health and Hospital Authority
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP