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Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.
To assess whether enteral nutrition fomulas based either on fat or glucose influence glucose homeostasis differently in critically ill medical patients. All patients are admitted to a tertiary ICU and require mechanical ventilation.
Resting energy expenditure is assessed at baseline in the fasting state by indirect calorimetry. Total energy demand is calculated and patients are randomized to receive fat-based or glucose-based nutrition which is administered continously for 7 days. Indirect calorimetry is repeated on days 3 and 7 under continous nutrition. During the study period, various parameters of glucose homeostasis are assessed. Daily, there will be at least 3 measurements of blood glucose, more if the treating physician deems it necessary. Daily average glucose, daily glucose variability, overall area under the curve for glucose are calculated. Furthermore, energy intake by nutrition, medications (i.e. propofol), and glucose infusion, as well as substrate intake, and insulin demand per 24hrs are determined daily. Adverse effects such as episodes of hyper- or hypoglycemia, cholestasis, hypertriglyceridemia, diarrhea, vomiting, and the amount of gastric residual volume are noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fat-based | Active Comparator | Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU |
|
| glucose-based | Active Comparator | Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diben, Fresenius Kabi | Other | Patients receive Diben continously for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| average daily glucose | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| insulin demand per 24 hrs | up to 7 days | |
| glucose variability | up to 7 days | |
| nutrition-related side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Zauner, MD | Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
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| Fresubin original fibre, Fresenius Kabi |
| Other |
Patients receive Fresubin original fibre continously for 7 days |
|
| 7 days |