Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study (ANUS1014)
|ClinicalTrials.gov Identifier: NCT01463878|
Recruitment Status : Terminated (Unlikely to show statistical significance and slow recruitment.)
First Posted : November 2, 2011
Results First Posted : September 28, 2012
Last Update Posted : October 5, 2012
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage Intracranial Hemorrhage Ischemic Strokes Subdural Hematoma||Dietary Supplement: Glycerna Dietary Supplement: Jevity - Control Diet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Enteral Nutrition and Glycemic Variability NICU Study|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula.
Dietary Supplement: Glycerna
Diabetes specific formula
Active Comparator: Control - Jevity
The control arm of the study. Patients to receive Jevity. The volume /rate of Jevity will be determined by the dietician according to standard formula.
Dietary Supplement: Jevity - Control Diet
- Glycemic Variability [ Time Frame: Entire ICU stay. Up to 14 days in the ICU (average about 7 days) ]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 between the control and intervention groups.
- Quadriceps Muscle Volume [ Time Frame: First versus last measurment in ICU. Up to 14 days (average 7 days) ]The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463878
|United States, Virginia|
|Sentara Norfolk General Hospital|
|Norfolk, Virginia, United States, 23507|
|Principal Investigator:||Paul e Marik, MD||EVMS|