Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucerna | Active Comparator | Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding. |
|
| Fresubin | Active Comparator | Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucerna | Dietary Supplement | Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose variability | The primary outcome is the extent of glucose variability, defined as the mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of insulin use | In units/day. | 72 hours |
| Time in target range | Defined as a glucose between 6-9 mmol/l in minutes/day. | 72 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter HJ van der Voort, Prof. dr. | Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis | Amsterdam | North Holland | 1091 AC | Netherlands |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 4, 2018 | |
| Reset | Nov 2, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 4, 2018 | Nov 2, 2018 |
| ID | Term |
|---|---|
| C530986 | Glucerna |
| C048418 | Fresubin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fresubin | Dietary Supplement | Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding. |
|
| Mean glucose and standarddeviation | Defined as the mean sensor glucose and standarddeviation in mmol/l. | 72 hours |
| Number of severe hypoglycemic events | Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. | 72 hours |
| Duration of severe hypoglycemic events | Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day. | 72 hours |
| Number of severe hyperglycemic events | Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. | 72 hours |
| Duration of severe hyperglycemic events | Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day. | 72 hours |
| Daily calorie administration | Defined as amount of calories received per patient/day. | 72 hours |
| Daily nutrient administration | Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day. | 72 hours |