Enteral Nutrition and Glucose Homeostasis

Phase 4

Completed

• Conditions: Hyperglycemia Stress
• Interventions: Other: Fresubin original fibre, Fresenius Kabi; Other: Diben, Fresenius Kabi

• Registration Number: NCT03012867
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2014-07
• Study Completion: 2016-09
• Status Verified: 2017-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-05
• Last Update Submitted: 2017-01-05
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• medical patient with need for mechanical ventilation
• FiO2 requirement < 60%
• need for nutritional support

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glucose-based	Fresubin original fibre, Fresenius Kabi	Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU
fat-based	Diben, Fresenius Kabi	Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU

Primary Outcome Measures

Name	Time	Method
average daily glucose	up to 7 days

Secondary Outcome Measures

Name	Time	Method
glucose variability	up to 7 days
insulin demand per 24 hrs	up to 7 days
nutrition-related side effects	7 days

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria