Trial Outcomes & Findings for Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study (NCT NCT01463878)
NCT ID: NCT01463878
Last Updated: 2012-10-05
Results Overview
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.
TERMINATED
PHASE4
14 participants
Entire ICU stay. Up to 14 days in the ICU (average about 7 days)
2012-10-05
Participant Flow
18 patients were consented and only 14 enrolled. 4 dropped out as failed to meet the inclusion criteria after consent; were bale to take food by mouth
Participant milestones
| Measure |
Glycerna
Diabetic specific formula
|
Control - Jevity
The control arm of the study. Patients to receive Jevity
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Glycerna
Diabetic specific formula
|
Control - Jevity
The control arm of the study. Patients to receive Jevity
|
|---|---|---|
|
Overall Study
no longer met criteria for tube feed
|
2
|
2
|
Baseline Characteristics
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study
Baseline characteristics by cohort
| Measure |
Glycerna
n=9 Participants
Diabetic specific formula
|
Control - Jevity
n=9 Participants
The control arm of the study. Patients to receive Jevity
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age Continuous
|
72 years
STANDARD_DEVIATION 12 • n=5 Participants
|
74 years
STANDARD_DEVIATION 9 • n=7 Participants
|
73 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Glycerna
n=7 Participants
Diabetic specific formula
|
Control - Jevity
n=7 Participants
The control arm of the study. Patients to receive Jevity
|
|---|---|---|
|
Glycemic Variability
|
168 mg/dl (MAGE)
Standard Deviation 40
|
166 mg/dl (MAGE)
Standard Deviation 41
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Glycerna
Control - Jevity
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place