Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Study Overview
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Brief Summary
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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.

Official Title
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Enteral Nutrition and Glycemic Variability NICU Study

Conditions
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Subarachnoid Hemorrhage, Intracranial Hemorrhage, Ischemic Strokes, Subdural Hematoma

Intervention / Treatment
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* Dietary Supplement: Glycerna
* Dietary Supplement: Jevity - Control Diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycerna<br>Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula. | Dietary Supplement: Glycerna<br>* Diabetes specific formula<br>|
| Active Comparator: Control - Jevity<br>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. | Dietary Supplement: Jevity - Control Diet<br>* Control Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Variability | 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. | Entire ICU stay. Up to 14 days in the ICU (average about 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps Muscle Volume | 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. | First versus last measurment in ICU. Up to 14 days (average 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycemic control, glycemic variability, mean blood glucose level