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

Not Applicable

Completed

• Conditions: Critically Ill
• Interventions: Other: Indirect Calorimetry

• Registration Number: NCT03249051
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-11
• Study First Submitted: 2017-06-25
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-09
• Primary Completion: 2017-08-15
• Study Completion: 2017-08-15
• Study First Posted: 2017-08-15
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indirect Calorimetry	Indirect Calorimetry	The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Hohenheim; 🇩🇪 Stuttgart, Germany