Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Phase 4

Terminated

Conditions: Subarachnoid Hemorrhage
Intracranial Hemorrhage
Ischemic Strokes
Subdural Hematoma

Interventions: Dietary Supplement: Glycerna
Dietary Supplement: Jevity - Control Diet

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 and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.

Secondary Objectives:

To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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)

Arm && Interventions

Group	Intervention	Description
Glycerna	Glycerna	Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula.
Control - Jevity	Jevity - Control Diet	The control arm of the study. Patients to receive Jevity. The volume /rate of Jevity will be determined by the dietician according to standard formula.

Primary Outcome Measures

Name	Time	Method
Glycemic Variability	Entire ICU stay. Up to 14 days in the ICU (average about 7 days)	The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.

Secondary Outcome Measures

Name	Time	Method
Quadriceps Muscle Volume	First versus last measurment in ICU. Up to 14 days (average 7 days)	The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.