Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients. (ONCA)

October 4, 2017 updated by: University of Hohenheim

Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.

The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70599
        • University of Hohenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18 years
  • mechanical ventilation
  • an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen
  • possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)
  • possibility to perform Bioelectrical Impedance Analysis (BIA)
  • underlying indication for enteral or/and parenteral nutritional support
  • written informed consent from the patient or a legal authorized person

Exclusion Criteria:

  • cardiac pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indirect Calorimetry
The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.
Other: Indirect Calorimetry
Energy need is being determined using indirect Calorimetry
No Intervention: Standard Care
This group receives nutrition supply according to the hospital routine ("standard care")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase angle (PhA)
Time Frame: PhA was measured between one and 90 days (during ICU stay)
The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.
PhA was measured between one and 90 days (during ICU stay)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitrogen Balance
Time Frame: Nitrogen Balance was measured between one and 90 days (during ICU stay)
Difference between intervention and control group between hospital admission and discharge.
Nitrogen Balance was measured between one and 90 days (during ICU stay)
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Time Frame: ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
Difference between intervention and control group between hospital admission and discharge.
ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
Length of hospital stay in days
Time Frame: Length of hospital stay was measured between one and 180 days
Difference between intervention and control group between hospital admission and discharge.
Length of hospital stay was measured between one and 180 days
Length of stay in intensive care unit (ICU) in days
Time Frame: Length of ICU stay was measured between one and 90 days
Difference between intervention and control group between hospital admission and discharge.
Length of ICU stay was measured between one and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Investigators

  • Principal Investigator: Stephan C Bischoff, University of Hohenheim, 70599 Stuttgart, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2016

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Indirect Calorimetry in ICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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