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

Critically Ill Clinical Trial

— ONCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249051
• Other study ID #: Indirect Calorimetry in ICU
• Status: Completed
• Phase: N/A
• First received: June 25, 2017
• Last updated: October 4, 2017
• Start date: January 11, 2016
• Est. completion date: August 15, 2017

Study information

• Verified date: August 2017
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• Indirect Calorimetry
Energy need is being determined using indirect Calorimetry

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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