Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study "ANUS1014"

Terminated

Phase 4 Results

Trial Description

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.

Trial Stopped: Unlikely to show statistical significance and slow recruitment.

Conditions

Interventions

  • Glycerna Dietary Supplement
    Intervention Desc: Diabetes specific formula
    ARM 1: Kind: Experimental
    Label: Glycerna
    Description: Diabetic specific formula
  • Jevity - Control Diet Dietary Supplement
    Intervention Desc: Control Diet
    ARM 1: Kind: Experimental
    Label: Control - Jevity
    Description: The control arm of the study. Patients to receive Jevity

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Glycemic variability Entire ICU stay. Up to 14 days in the ICU (average about 7 days) No
Secondary Quadriceps muscle volume First versus last measurment in ICU. Up to 14 days (average 7 days) No

Sponsors