Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.
ONCA
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
1 active site
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
January 11, 2016
CompletedFirst Submitted
Initial submission to the registry
June 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedOctober 6, 2017
August 1, 2017
1.6 years
June 25, 2017
October 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
PhA was measured between one and 90 days (during ICU stay)
Secondary Outcomes (4)
Nitrogen Balance
Nitrogen Balance was measured between one and 90 days (during ICU stay)
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
Length of hospital stay in days
Length of hospital stay was measured between one and 180 days
Length of stay in intensive care unit (ICU) in days
Length of ICU stay was measured between one and 90 days
Study Arms (2)
Indirect Calorimetry
EXPERIMENTALThe energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.
Standard Care
NO INTERVENTIONThis group receives nutrition supply according to the hospital routine ("standard care")
Interventions
Energy need is being determined using indirect Calorimetry
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- cardiac pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hohenheim
Stuttgart, 70599, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan C Bischoff
University of Hohenheim, 70599 Stuttgart, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2017
First Posted
August 15, 2017
Study Start
January 11, 2016
Primary Completion
August 15, 2017
Study Completion
August 15, 2017
Last Updated
October 6, 2017
Record last verified: 2017-08