NCT01463878

Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Enteral Nutrition and Glycemic Variability NICU Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Glycerna	Diabetes specific formula
DIETARY_SUPPLEMENT	Jevity - Control Diet	Control Diet

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-11-02
• Last updated: 2012-10-05
• Results posted: 2012-09-28

Locations

1 site across 1 country: United States