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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

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

NCT ID

NCT01463878

First Posted

October 24, 2011

Last Updated

October 3, 2012

Sponsor

Eastern Virginia Medical School

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

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

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

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

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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