Critically Ill Mechanically Ventilated Subjects
Conditions
Brief summary
To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.
Interventions
OTHERPeptamen Bariatric
Commercially available enteral diet
OTHERReplete
Commercially available enteral diet
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New admit to the ICU and expected to remain in ICU 5 days * Ventilator dependent up to 48 hours prior to admission to the study * Requiring tube feeding enteral nutrition (EN) 5 days * Expected to receive 50% of caloric needs within 72 hours * Body Mass Index 26-45
Exclusion criteria
* Trauma patients * Major surgery in past 30 days or planned for next 7 days * Diabetes mellitus (DM) type 1 * Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis * Pregnant or lactating * Non-functioning GI tract * Use of parenteral nutrition in past 30 days * Admitted with burns \> 20% body surface area * Traumatic brain injury * Hemodynamic instability that prevents delivery of EN \> 24hr * Unable to access GI tract for feeding via tube, unable to receive EN * Other contraindication to tube feeding * Any other condition that would not allow patient to complete the study protocol * Use of enteral formula at enrollment that cannot be changed to the investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl | First seven days in the ICU | Number of glycemic events outside the serum glucose range of 110-150 mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl) | First seven days in the ICU | Number of episodes of hypoglycemia (glucose \< 80 mg/dl) |
| Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl) | First seven days in the ICU | Number of episodes of hyperglycemia (glucose \> 180 mg/dl) |
| Glucose variability - Average glucose levels | First seven days in the ICU | Average glucose levels |
| Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl | First seven days in the ICU | Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl |
| Need for exogenous glucose administration | First seven days in the ICU | Number of times of administration and amount of glucose received |
| Nursing time | First seven days in the ICU | Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied |
| Need for exogenous insulin administration | First seven days in the ICU | Number of administrations, amount of insulin received, number of times insulin order adjusted, circulating C-peptide at baseline, day 3, 5 and 7 |
Countries
Canada, United States
Outcome results
None listed