Critically Ill Mechanically Ventilated Subjects Clinical Trial
Official title:
The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
| Verified date | January 2018 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Queen's University | Kingston | Ontario |
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | University of Chicago Medicine | Chicago | Illinois |
| United States | University of Kentucky Albert B. Chandler Hospital | Lexington | Kentucky |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Regions Hospital | Saint Paul | Minnesota |
| United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl | Number of glycemic events outside the serum glucose range of 110-150 mg/dl | First seven days in the ICU | |
| Secondary | Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl | Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl | First seven days in the ICU | |
| Secondary | Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl) | Number of episodes of hypoglycemia (glucose < 80 mg/dl) | First seven days in the ICU | |
| Secondary | Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl) | Number of episodes of hyperglycemia (glucose > 180 mg/dl) | First seven days in the ICU | |
| Secondary | Glucose variability - Average glucose levels | Average glucose levels | First seven days in the ICU | |
| Secondary | Need for exogenous insulin administration | Number of administrations, amount of insulin received, number of times insulin order adjusted, circulating C-peptide at baseline, day 3, 5 and 7 | First seven days in the ICU | |
| Secondary | Need for exogenous glucose administration | Number of times of administration and amount of glucose received | First seven days in the ICU | |
| Secondary | Nursing time | Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied | First seven days in the ICU |