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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249051
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critically Ill Other: Indirect Calorimetry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.
Actual Study Start Date : January 11, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine


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")



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249051


Locations
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Germany
University of Hohenheim
Stuttgart, Germany, 70599
Sponsors and Collaborators
University of Hohenheim
Investigators
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Principal Investigator: Stephan C Bischoff University of Hohenheim, 70599 Stuttgart, Germany
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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT03249051    
Other Study ID Numbers: Indirect Calorimetry in ICU
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes