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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critically Ill

Intervention / Treatment
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* Other: Indirect Calorimetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrogen Balance | 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) | 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 | 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 | Difference between intervention and control group between hospital admission and discharge. | Length of ICU stay was measured between one and 90 days |