Early Insulin and Development of ARDS

Completed · Phase 2

Conditions studied: Respiratory Distress Syndrome, Adult, Sepsis, Hyperglycemia

In brief

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.

Key facts

Study ID

NCT00605696

Run by

Albert Einstein College of Medicine

People needed

18

Starts

2008-04-01

Expected to finish

2013-09-01

Last updated by the study team

2018-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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