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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: Clinical Trial Phase 4 study, sponsored by Eastern Virginia Medical School.
NCT01463878 is a Phase 4 study that was terminated before completion, run by Eastern Virginia Medical School. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
Why NCT01463878 stopped before completion
NCT01463878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Glycerna is the first listed.
NCT01463878 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01463878's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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