Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Phase 4TerminatedNCT01463878

Eastern Virginia Medical School14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Subarachnoid Hemorrhage Intracranial Hemorrhage Ischemic Strokes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Entire ICU stay. Up to 14 days in the ICU (average about 7 days)

Secondary Outcomes

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.

Time frame: First versus last measurment in ICU. Up to 14 days (average 7 days)