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

This study has been terminated.
(Unlikely to show statistical significance and slow recruitment.)
Sponsor:
Information provided by (Responsible Party):
Paul Marik, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01463878
First received: October 24, 2011
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Subarachnoid Hemorrhage
Intracranial Hemorrhage
Ischemic Strokes
Subdural Hematoma
 Dietary Supplement: Glycerna
Dietary Supplement: Jevity - Control Diet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Enteral Nutrition and Glycemic Variability NICU Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • Glycemic Variability [ Time Frame: Entire ICU stay. Up to 14 days in the ICU (average about 7 days) ] [ Designated as safety issue: No ]
    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:
  • Quadriceps Muscle Volume [ Time Frame: First versus last measurment in ICU. Up to 14 days (average 7 days) ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463878

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

No publications provided

Responsible Party: Paul Marik, Chief of Pulmnary and Critical Care Medicine, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01463878     History of Changes
Other Study ID Numbers: ANUS1014
Study First Received: October 24, 2011
Results First Received: June 22, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
glycemic control
glycemic variability
mean blood glucose level

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hemorrhage
Stroke
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013