Evaluating the Effectiveness of Early Insulin Therapy in People at Risk for Developing Acute Lung Injury/Acute Respiratory Distress Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00605696
First received: January 18, 2008
Last updated: September 4, 2009
Last verified: September 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Plasma levels of free fatty acids, tumor necrosis factor-α, interleukin-6, and von Willebrand factor antigen [ Time Frame: Measured at Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Murray Lung Injury Score [ Time Frame: Measured at Day 7 ] [ Designated as safety issue: No ]

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
Experimental: 1
Participants will receive IIT within 6-12 hours after presenting to 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.
Active Comparator: 2
Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605696

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Investigators
Principal Investigator: Michelle Ng Gong, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Michelle Ng Gong, MD, MS, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00605696     History of Changes
Other Study ID Numbers: 542, HL086667
Study First Received: January 18, 2008
Last Updated: September 4, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Acute Respiratory Distress Syndrome
Acute Lung Injury

Additional relevant MeSH terms:
Hyperglycemia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Sepsis
Lung Injury
Glucose Metabolism Disorders
Metabolic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Thoracic Injuries
Wounds and Injuries
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014