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Completed

NCT Number: NCT03249051

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

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hohenheim

Stuttgart, 70599, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indirect Calorimetry

Other

Energy need is being determined using indirect Calorimetry

Primary outcomes

  1. Phase angle (PhA)

    Time frame: 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 outcomes

  1. Nitrogen Balance

    Time frame: Nitrogen Balance was measured between one and 90 days (during ICU stay)

    Difference between intervention and control group between hospital admission and discharge.

  2. Extracellular to body cell mass ratio (ECM/BCM - Ratio)

    Time frame: ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)

    Difference between intervention and control group between hospital admission and discharge.

  3. Length of hospital stay in days

    Time frame: Length of hospital stay was measured between one and 180 days

    Difference between intervention and control group between hospital admission and discharge.

  4. Length of stay in intensive care unit (ICU) in days

    Time frame: Length of ICU stay was measured between one and 90 days

    Difference between intervention and control group between hospital admission and discharge.

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Acronym: ONCA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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