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

• 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
  
  

• 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
  
  

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.