Back to resultsOptimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients. (ONCA)
Primary Purpose
Critically Ill
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Indirect Calorimetry
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill
Eligibility 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
Sites / Locations
- University of Hohenheim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Indirect Calorimetry
Standard Care
Arm Description
The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.
This group receives nutrition supply according to the hospital routine ("standard care")
Outcomes
Primary Outcome Measures
Phase angle (PhA)
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
Nitrogen Balance
Difference between intervention and control group between hospital admission and discharge.
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Difference between intervention and control group between hospital admission and discharge.
Length of hospital stay in days
Difference between intervention and control group between hospital admission and discharge.
Length of stay in intensive care unit (ICU) in days
Difference between intervention and control group between hospital admission and discharge.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03249051
Brief Title
Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.
Acronym
ONCA
Official Title
Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 11, 2016 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hohenheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indirect Calorimetry
Arm Type
Experimental
Arm Description
The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This group receives nutrition supply according to the hospital routine ("standard care")
Intervention Type
Other
Intervention Name(s)
Indirect Calorimetry
Intervention Description
Energy need is being determined using indirect Calorimetry
Primary Outcome Measure Information:
Title
Phase angle (PhA)
Description
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.
Time Frame
PhA was measured between one and 90 days (during ICU stay)
Secondary Outcome Measure Information:
Title
Nitrogen Balance
Description
Difference between intervention and control group between hospital admission and discharge.
Time Frame
Nitrogen Balance was measured between one and 90 days (during ICU stay)
Title
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Description
Difference between intervention and control group between hospital admission and discharge.
Time Frame
ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
Title
Length of hospital stay in days
Description
Difference between intervention and control group between hospital admission and discharge.
Time Frame
Length of hospital stay was measured between one and 180 days
Title
Length of stay in intensive care unit (ICU) in days
Description
Difference between intervention and control group between hospital admission and discharge.
Time Frame
Length of ICU stay was measured between one and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C Bischoff
Organizational Affiliation
University of Hohenheim, 70599 Stuttgart, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hohenheim
City
Stuttgart
ZIP/Postal Code
70599
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.
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