Phase 2
N=18
Early Insulin and Development of ARDS
Respiratory Distress Syndrome, Adult · Sepsis · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00605696 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen |
— | — |
| SECONDARY Murray Lung Injury Score |
0.333; 0.323 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00605696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.