Back to resultsEnteral Nutrition and Glucose Homeostasis
Primary Purpose
Hyperglycemia Stress
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Diben, Fresenius Kabi
Fresubin original fibre, Fresenius Kabi
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia Stress focused on measuring criticall illness, enteral nutrition
Eligibility Criteria
Inclusion Criteria:
- medical patient with need for mechanical ventilation
- FiO2 requirement < 60%
- need for nutritional support
Exclusion Criteria:
- contraindications against nutritional therapy
- hemodynamic shock (lactate of ≥ 4 mmol/l)
- severe hypertriglyceridemia (≥ 450 mg/dl)
- contraindications against enteral nutrion (intestinal obstruction, disruption or severe bleeding of upper gastrointestinal tract)
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fat-based
glucose-based
Arm Description
Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU
Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU
Outcomes
Primary Outcome Measures
average daily glucose
Secondary Outcome Measures
insulin demand per 24 hrs
glucose variability
nutrition-related side effects
Full Information
NCT ID
NCT03012867
First Posted
January 5, 2017
Last Updated
January 5, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03012867
Brief Title
Enteral Nutrition and Glucose Homeostasis
Official Title
Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia Stress
Keywords
criticall illness, enteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fat-based
Arm Type
Active Comparator
Arm Description
Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU
Arm Title
glucose-based
Arm Type
Active Comparator
Arm Description
Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU
Intervention Type
Other
Intervention Name(s)
Diben, Fresenius Kabi
Intervention Description
Patients receive Diben continously for 7 days
Intervention Type
Other
Intervention Name(s)
Fresubin original fibre, Fresenius Kabi
Intervention Description
Patients receive Fresubin original fibre continously for 7 days
Primary Outcome Measure Information:
Title
average daily glucose
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
insulin demand per 24 hrs
Time Frame
up to 7 days
Title
glucose variability
Time Frame
up to 7 days
Title
nutrition-related side effects
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medical patient with need for mechanical ventilation
FiO2 requirement < 60%
need for nutritional support
Exclusion Criteria:
contraindications against nutritional therapy
hemodynamic shock (lactate of ≥ 4 mmol/l)
severe hypertriglyceridemia (≥ 450 mg/dl)
contraindications against enteral nutrion (intestinal obstruction, disruption or severe bleeding of upper gastrointestinal tract)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Zauner, MD
Organizational Affiliation
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Enteral Nutrition and Glucose Homeostasis
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