Evaluating the Effectiveness of Early Insulin Therapy in People at Risk for Developing Acute Lung Injury/Acute Respiratory Distress Syndrome

• Plasma levels of free fatty acids, tumor necrosis factor-α, interleukin-6, and von Willebrand factor antigen [ Time Frame: Measured at Day 7 ] [ Designated as safety issue: No ]
  

• Murray Lung Injury Score [ Time Frame: Measured at Day 7 ] [ Designated as safety issue: No ]
  

ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. Common causes include pneumonia, lung trauma, and sepsis, a condition that can lead to widespread inflammation and blood clotting in response to an infection. Recent studies have shown that insulin, which is regularly used to control blood sugar levels, may prevent or lessen the risk of lung tissue inflammation and/or lung injury related to sepsis. Research has shown that critically ill ICU patients often benefit from receiving IIT, but it is not known if IIT can prevent the onset of ALI/ARDS. Therapies to prevent ALI/ARDS should occur early, preferably even prior to ICU admission, because at least 38% of people with ALI/ARDS are diagnosed with the condition once they reach the ICU. The purpose of this study is to determine whether IIT administered to critically ill patients in the emergency department (ED) is more beneficial at preventing ALI/ARDS than IIT administered to patients 48 hours after ICU admission.

This study will enroll people who are hospitalized with high blood sugar levels and severe sepsis. Participants will be randomly assigned to receive IIT within 6-12 hours of ED presentation to target 80-110 mg/dl or target 150-180 mg/dl for 48 hours after admission to the ICU followed by usual care. Prior to ICU admission and 1, 3, and 7 days after ICU admission, blood will be collected and analyzed for markers of inflammation and lung injury. Blood samples will be stored for future research studies. While participants are in the hospital, their medical records will be reviewed to gather information on medical and family history, demographics, vital signs, laboratory test results, x-ray findings, and lung function. Study researchers will also monitor participants for the development of severe lung failure or other organ failures.