Intracranial Hemorrhage, Ischemic Strokes, Subarachnoid Hemorrhage, Subdural Hematoma
Conditions
Keywords
glycemic control, glycemic variability, mean blood glucose level
Brief 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.
Interventions
DIETARY_SUPPLEMENTGlycerna
Diabetes specific formula
DIETARY_SUPPLEMENTJevity - Control Diet
Control Diet
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 89 years old * Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage * Patients who are expected to stay in the ICU for at least 5 days * Hyperglycemia is not an inclusion criteria
Exclusion criteria
* Patients who have received or will be treated with systemic corticosteroids. * Patients who will be receiving high doses of propofol (\>40 cc/hr) * Patients with type 1 Diabetes * Patients with sepsis or acute trauma * Patients with an expected stay in the ICU of less than 4 days * Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components * Pregnant and lactating patients * Patients with prior history of gastroparesis * Patients with acute kidney failure (creatinine \> 2.5mg/dl) * Patients with acute liver failure (bilirubin \> 2.0 mg/dl)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Variability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Volume | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Glycerna Diabetic specific formula | 9 |
| Control - Jevity The control arm of the study. Patients to receive Jevity | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | no longer met criteria for tube feed | 2 | 2 |
Baseline characteristics
| Characteristic | Control - Jevity | Glycerna | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age Continuous | 74 years STANDARD_DEVIATION 9 | 72 years STANDARD_DEVIATION 12 | 73 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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.
Time frame: Entire ICU stay. Up to 14 days in the ICU (average about 7 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glycerna | Glycemic Variability | 168 mg/dl (MAGE) | Standard Deviation 40 |
| Control - Jevity | Glycemic Variability | 166 mg/dl (MAGE) | Standard Deviation 41 |
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.
Time frame: First versus last measurment in ICU. Up to 14 days (average 7 days)