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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01463878
Other study ID # ANUS1014
Secondary ID
Status Terminated
Phase Phase 4
First received October 24, 2011
Last updated October 3, 2012
Start date November 2011
Est. completion date June 2012

Study information

Verified date October 2012
Source Eastern Virginia Medical School
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 89 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Dietary Supplement:
Glycerna
Diabetes specific formula
Jevity - Control Diet
Control Diet

Locations

Country Name City State
United States Sentara Norfolk General Hospital Norfolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
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