Early Insulin and Development of ARDS

NCT ID: NCT00605696

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-09-30

Brief 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.

Detailed Description

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 insulin to target 80-110 mg/dl , but it is not known if insulin to target these levels 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 insulin to target 80-110 mg/dl administered to critically ill patients in the emergency department (ED) is more beneficial at preventing ALI/ARDS than insulin to target 150-180 mg/dl 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.

Conditions

Respiratory Distress Syndrome, Adult; Sepsis; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Participants will receive insulin to target glucose 80-110 mg/dl within 6-12 hours after presenting to ED.

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.

2

Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.

Interventions

Insulin

Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Michelle Gong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Ng Gong, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

R01HL086667

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009-462

Identifier Type: -

Identifier Source: org_study_id