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Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

NCT01463878 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-10-05

Study results available
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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.

Conditions

  • Subarachnoid Hemorrhage
  • Intracranial Hemorrhage
  • Ischemic Strokes
  • Subdural Hematoma

Interventions

DIETARY_SUPPLEMENT

Glycerna

Diabetes specific formula

DIETARY_SUPPLEMENT

Jevity - Control Diet

Control Diet

Sponsors & Collaborators

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Paul e Marik, MD · EVMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463878 on ClinicalTrials.gov