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

NCT ID: NCT03249051

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-11

Study Completion Date

2017-08-15

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.

Detailed Description

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Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indirect Calorimetry

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

Group Type EXPERIMENTAL

Indirect Calorimetry

Intervention Type OTHER

Energy need is being determined using indirect Calorimetry

Standard Care

This group receives nutrition supply according to the hospital routine ("standard care")

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Indirect Calorimetry

Energy need is being determined using indirect Calorimetry

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan C Bischoff

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim, 70599 Stuttgart, Germany

Locations

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University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Indirect Calorimetry in ICU

Identifier Type: -

Identifier Source: org_study_id