Critically Ill
Conditions
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.
Interventions
OTHERIndirect Calorimetry
Energy need is being determined using indirect Calorimetry
Sponsors
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase angle (PhA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Nitrogen Balance | Nitrogen Balance was measured between one and 90 days (during ICU stay) | Difference between intervention and control group between hospital admission and discharge. |
| Extracellular to body cell mass ratio (ECM/BCM - Ratio) | ECM/BCM-Ratio was measured between one and 90 days (during ICU stay) | Difference between intervention and control group between hospital admission and discharge. |
| Length of hospital stay in days | Length of hospital stay was measured between one and 180 days | Difference between intervention and control group between hospital admission and discharge. |
| Length of stay in intensive care unit (ICU) in days | Length of ICU stay was measured between one and 90 days | Difference between intervention and control group between hospital admission and discharge. |
Countries
Germany
Outcome results
None listed