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Unlikely to show statistical significance and slow recruitment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerna | Experimental | Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula. |
|
| Control - Jevity | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerna | Dietary Supplement | Diabetes specific formula |
| |
| Jevity - Control Diet |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Variability | 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. | Entire ICU stay. Up to 14 days in the ICU (average about 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Muscle Volume | 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. | First versus last measurment in ICU. Up to 14 days (average 7 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul e Marik, MD | EVMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycerna | Diabetic specific formula |
| FG001 | Control - Jevity | The control arm of the study. Patients to receive Jevity |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycerna | Diabetic specific formula |
| BG001 | Control - Jevity | The control arm of the study. Patients to receive Jevity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Variability | 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. | Posted | Mean | Standard Deviation | mg/dl (MAGE) | Entire ICU stay. Up to 14 days in the ICU (average about 7 days) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glycerna | Diabetic specific formula |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Marik | Eastern Virginia Medical School | 757-446-8910 | marikpe@evms.edu |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D000083242 | Ischemic Stroke |
| D006408 | Hematoma, Subdural |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Dietary Supplement |
Control Diet |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The control arm of the study. Patients to receive Jevity |
|
|
| Secondary | Quadriceps Muscle Volume | 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. | Not Posted | First versus last measurment in ICU. Up to 14 days (average 7 days) |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control - Jevity | The control arm of the study. Patients to receive Jevity | 0 | 7 | 0 | 7 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D006406 | Hematoma |
| D014947 | Wounds and Injuries |