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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00605696 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome, Adult Sepsis Hyperglycemia |
Drug: Insulin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome |
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive IIT while in the ED.
|
Drug: Insulin
Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU.
|
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2: Active Comparator
Participants will receive IIT 48 hours after ICU admission.
|
Drug: Insulin
Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU.
|
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 either while in the ED or 48 hours after admission to the ICU. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Adam Wright | 212-241-40358 | Adam.Wright@mssm.edu |
| Contact: Michelle Ng Gong, MD, MS | 212-241-6052 | Michelle.Gong@mssm.edu |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Michelle Ng Gong, MD, MS | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Mount Sinai School of Medicine ( Michelle Ng Gong, MD, MS ) |
| Study ID Numbers: | 542, HL086667 |
| Study First Received: | January 18, 2008 |
| Last Updated: | November 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00605696 |
| Health Authority: | United States: Federal Government |
|
Acute Respiratory Distress Syndrome Acute Lung Injury |
|
Sepsis Metabolic Diseases Hyperglycemia Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome Metabolic disorder Glucose Metabolism Disorders Insulin |
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Hypoglycemic Agents Pathologic Processes Disease |
Syndrome Physiological Effects of Drugs Pharmacologic Actions |
