Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study (ANUS1014)

Enteral Nutrition and Glycemic Variability NICU Study

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 Overview

• Status: Terminated
• Conditions: Subarachnoid Hemorrhage; Intracranial Hemorrhage; Ischemic Strokes; Subdural Hematoma
• Intervention / Treatment: Dietary supplement: Glycerna; Dietary supplement: Jevity - Control Diet

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Glycerna; Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula.	Dietary supplement: Glycerna; Diabetes specific formula
ACTIVE_COMPARATOR: Control - Jevity; 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; Control Diet

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Investigators: Principal Investigator: Paul e Marik, MD, EVMS

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (ESTIMATE): November 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: glycemic variability; glycemic control; mean blood glucose level
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Intracranial Hemorrhage, Traumatic; Ischemic Stroke; Hemorrhage; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Hematoma; Hematoma, Subdural
• Other Study ID Numbers: ANUS1014