Enteral Nutrition and Glucose Homeostasis

NCT ID: NCT03012867

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2016-09-30

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.

Conditions

Hyperglycemia Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fat-based

Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU

Group Type: ACTIVE_COMPARATOR

Diben, Fresenius Kabi

Intervention Type: OTHER

Patients receive Diben continously for 7 days

glucose-based

Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU

Group Type: ACTIVE_COMPARATOR

Fresubin original fibre, Fresenius Kabi

Intervention Type: OTHER

Patients receive Fresubin original fibre continously for 7 days

Interventions

Diben, Fresenius Kabi

Patients receive Diben continously for 7 days

Intervention Type: OTHER

Fresubin original fibre, Fresenius Kabi

Patients receive Fresubin original fibre continously for 7 days

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Marlene Wewalka

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Zauner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

NUTR1

Identifier Type: -

Identifier Source: org_study_id