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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Denver Health and Hospital Authority
Sponsor:
Collaborators:
University of Colorado, Denver
Information provided by (Responsible Party):
Ernest Moore, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01667666
First received: August 10, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Acute Lung Injury
Adult Respiratory Distress Syndrome
Drug: Nebulized hypertonic saline
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • change in the PaO2/FiO2 (P/F) ratios [ Time Frame: baseline and every 6 hours for 36 hours ] [ Designated as safety issue: Yes ]
    A decrease greater than 20% will trigger DSMB review


Secondary Outcome Measures:
  • death within 28 days [ Time Frame: 28 days or discharge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult > 18 years of age
  • trauma with an injury severity score > 15 and < 25
  • ≤10 units of RBC in the first 6 hours (as this is a major risk factor for ARDS and MOF in this population)
  • mechanical ventilation for at least 1 day based on a standard resuscitation protocol

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667666

Contacts
Contact: Theresa Chin, MD 303-724-6308 theresa.chin@ucdenver.edu

Locations
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Ernest E. Moore, M.D.         
Sponsors and Collaborators
Denver Health and Hospital Authority
University of Colorado, Denver
Investigators
Principal Investigator: Ernest E Moore, MD Denver Health and Hospital Authority
  More Information

No publications provided

Responsible Party: Ernest Moore, Professor of Surgery, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01667666     History of Changes
Other Study ID Numbers: COMIRB #11-0706
Study First Received: August 10, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Denver Health and Hospital Authority:
trauma
acute lung injury
adult respiratory distress syndrome

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Lung Injury
Wounds and Injuries
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on August 28, 2014