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.
Brief Title
Early Insulin and Development of ARDS
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Respiratory Distress Syndrome, Adult
Sepsis
Hyperglycemia
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
* 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
Inclusion 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)
* 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)
Gender
All
Gender Based
false
Keywords
Acute Respiratory Distress Syndrome
Acute Lung Injury
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00605696
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2009-462
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome
Primary Outcomes
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 1, 3 and 7
Secondary Ids
Secondary Id
R01HL086667
Secondary Outcomes
Outcome Description
Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score.
Outcome Time Frame
Measured at Day 3
Outcome Measure
Murray Lung Injury Score
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michelle Gong
Investigator Email
mgong@montefiore.org
Investigator Phone
718-920-5464