Early Insulin and Development of ARDS

NCT00605696 | Completed Phase 2 Results DMC

• 2 other identifiers: 2009-462R01HL086667
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Adult; Sepsis; Hyperglycemia

Keywords

Acute Respiratory Distress Syndrome; Acute Lung Injury

Outcome Measures

Primary Outcomes (1)

• Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen

  Measured at Day 1, 3 and 7

Secondary Outcomes (1)

• Murray Lung Injury Score

  Measured at Day 3

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Insulin

2

ACTIVE COMPARATOR

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

Drug: Insulin

Interventions

Insulin DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Sepsis; Hyperglycemia; Acute Lung Injury

Interventions

Insulin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lung Injury

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michelle Ng Gong, MD, MS
• Organization: Albert Einstein College of Medicine of Yeshiva University

mgong@montefiore.org

718 920 5464

Study Officials

• Michelle Ng Gong, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2013
• Last Updated: May 7, 2018
• Results First Posted: April 10, 2017

Record last verified: 2018-04

Locations

US (1)