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

• ClinicalTrials.gov Identifier: NCT01463878
• Recruitment Status: Terminated
• First Posted: November 2, 2011
• Results First Posted: September 28, 2012
• Last Update Posted: October 5, 2012
• Sponsor: Eastern Virginia Medical School
• Information provided by (Responsible Party): Paul Marik, Eastern Virginia Medical School

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Subarachnoid Hemorrhage; Intracranial Hemorrhage; Ischemic Strokes; Subdural Hematoma	Dietary Supplement: Glycerna; Dietary Supplement: Jevity - Control Diet	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Enteral Nutrition and Glycemic Variability NICU Study
• Study Start Date: November 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Glycemic Variability [ Time Frame: 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 :

1. Quadriceps Muscle Volume [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Virginia

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Eastern Virginia Medical School

Investigators

• Principal Investigator: Paul e Marik, MD; EVMS

More Information

• Responsible Party: Paul Marik, Chief of Pulmnary and Critical Care Medicine, Eastern Virginia Medical School
• ClinicalTrials.gov Identifier: NCT01463878
• Other Study ID Numbers: ANUS1014
• First Posted: November 2, 2011
• Results First Posted: September 28, 2012
• Last Update Posted: October 5, 2012
• Last Verified: October 2012

Keywords provided by Paul Marik, Eastern Virginia Medical School:

glycemic control; glycemic variability; mean blood glucose level

Additional relevant MeSH terms:

Ischemic Stroke; Subarachnoid Hemorrhage; Hematoma, Subdural; Intracranial Hemorrhages; Hemorrhage; Hematoma; Pathologic Processes; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhage, Traumatic; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries