NCT03012867

Brief Summary

Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

4.1 years

First QC Date

January 5, 2017

Last Update Submit

January 5, 2017

Conditions

Hyperglycemia Stress

Keywords

criticall illnessenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • average daily glucose

    up to 7 days

Secondary Outcomes (3)

  • insulin demand per 24 hrs

    up to 7 days

  • glucose variability

    up to 7 days

  • nutrition-related side effects

    7 days

Study Arms (2)

fat-based

ACTIVE COMPARATOR

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

Other: Diben, Fresenius Kabi

glucose-based

ACTIVE COMPARATOR

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

Other: Fresubin original fibre, Fresenius Kabi

Interventions

Diben, Fresenius KabiOTHER

Patients receive Diben continously for 7 days

fat-based
Fresubin original fibre, Fresenius KabiOTHER

Patients receive Fresubin original fibre continously for 7 days

glucose-based

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

  • Christian Zauner, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 6, 2017

Study Start

June 1, 2010

Primary Completion

July 1, 2014

Study Completion

September 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)