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

Primary Purpose

Subarachnoid Hemorrhage, Intracranial Hemorrhage, Ischemic Strokes

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glycerna
Jevity - Control Diet
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring glycemic control, glycemic variability, mean blood glucose level

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glycerna

Control - Jevity

Arm Description

Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 24, 2011
Last Updated
October 3, 2012
Sponsor
Eastern Virginia Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01463878
Brief Title
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study
Acronym
ANUS1014
Official Title
Enteral Nutrition and Glycemic Variability NICU Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Unlikely to show statistical significance and slow recruitment.
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Virginia Medical School

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Intracranial Hemorrhage, Ischemic Strokes, Subdural Hematoma
Keywords
glycemic control, glycemic variability, mean blood glucose level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycerna
Arm Type
Experimental
Arm Description
Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula.
Arm Title
Control - Jevity
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glycerna
Intervention Description
Diabetes specific formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Jevity - Control Diet
Intervention Description
Control Diet
Primary Outcome Measure Information:
Title
Glycemic Variability
Description
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 Outcome Measure Information:
Title
Quadriceps Muscle Volume
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul e Marik, MD
Organizational Affiliation
EVMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

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