Status:
TERMINATED
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study
Lead Sponsor:
Eastern Virginia Medical School
Conditions:
Subarachnoid Hemorrhage
Intracranial Hemorrhage
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief Summary
Primary Objective: To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose a...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 89 years old
- Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage
- Patients who are expected to stay in the ICU for at least 5 days
- Hyperglycemia is not an inclusion criteria
Exclusion
- Patients who have received or will be treated with systemic corticosteroids.
- Patients who will be receiving high doses of propofol (\>40 cc/hr)
- Patients with type 1 Diabetes
- Patients with sepsis or acute trauma
- Patients with an expected stay in the ICU of less than 4 days
- Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components
- Pregnant and lactating patients
- Patients with prior history of gastroparesis
- Patients with acute kidney failure (creatinine \> 2.5mg/dl)
- Patients with acute liver failure (bilirubin \> 2.0 mg/dl)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01463878
Start Date
November 1 2011
End Date
June 1 2012
Last Update
October 5 2012
Active Locations (1)
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1
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507