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Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome

Phase 2
18 Years
Open (Enrolling)
Respiratory Distress Syndrome, Adult, Sepsis, Hyperglycemia

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Trial Information

Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Plasma levels of free fatty acids, tumor necrosis factor-α, interleukin-6, and von Willebrand factor antigen

Outcome Time Frame:

Measured at Day 7

Safety Issue:


Principal Investigator

Michelle Ng Gong, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Federal Government

Study ID:




Start Date:

April 2008

Completion Date:

September 2012

Related Keywords:

  • Respiratory Distress Syndrome, Adult
  • Sepsis
  • Hyperglycemia
  • Acute Respiratory Distress Syndrome
  • Acute Lung Injury
  • Hyperglycemia
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome, Adult
  • Acute Lung Injury
  • Sepsis
  • Lung Injury



Montefiore Medical Center Bronx, New York  10467-2490