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NCT01463878 · ClinicalTrials.gov registry record · Phase 4
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study
A Phase 4 study, sponsored by Eastern Virginia Medical School.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01463878 is a Phase 4 study that was terminated before completion, run by Eastern Virginia Medical School. The registered enrollment target is 14 participants.
The verdict
NCT01463878, a Phase 4 study, was terminated before completion, sponsored by Eastern Virginia Medical School.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Glycerna
- DIETARY_SUPPLEMENT Jevity - Control Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01463878
The ClinicalTrials.gov registry entry for NCT01463878 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Virginia Medical School, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Glycerna is the first listed.
NCT01463878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01463878 about?
NCT01463878 is a clinical study titled "Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study". 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. Bloo...
What is the current status of trial NCT01463878?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2011-11. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01463878?
The interventions under investigation include: Glycerna (DIETARY_SUPPLEMENT), Jevity - Control Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01463878?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
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