Early Insulin and Development of ARDS

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an original injury or illness, and people with ALI/ARDS typically require care in the intensive care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of this study is to examine if early infusions of insulin, known as intensive insulin therapy (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars and severe infections.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; National Heart, Lung, and Blood Institute (NHLBI)
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Diagnosed with severe sepsis, which is defined as sepsis AND one or more signs of organ dysfunction or hypotension

• Hyperglycemia (i.e., glucose level greater than 130 mg/dL on one or more tests)

Exclusion Criteria:

• Diabetic ketoacidosis

• Severe chronic liver disease with Child-Pugh score greater than 10 (Class C)

• Documented episodes of blood or plasma glucose less than 60 mg/dL within 24 hours of study entry

• Lack of any available IV access for insulin infusion

• Pregnant

• Known advanced directives against intubation or aggressive ICU care

• Inability to be enrolled into the study in the 12 hours following admission to the ED