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Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy

NCT02503527 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-03-31

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

OTHER

Diben 1.5 kcal HP

Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) \> 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).

OTHER

Fresubin HP Energy Fibre (1.5 kcal)

Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) \> 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).

Sponsors & Collaborators

  • OE Clinical Trial Center (KKS) Universität Innsbruck

    collaborator UNKNOWN

  • International Medical Research - Partner GmbH

    collaborator OTHER

  • dsh statistical services GmbH

    collaborator UNKNOWN

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Ronny Beer, PD Dr. med. · Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-08-31
Completion
2018-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503527 on ClinicalTrials.gov