- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552446
Energy Expenditure in ICU Patients Using Predictive Formulas and Various Body Weights Versus Indirect Calorimetry
September 16, 2015 updated by: HEIDEGGER CP, University Hospital, Geneva
Indirect Calorimetry an Essential Tool in the Intensive Care: Comparison of the Energy Expenditure Calculated With Different Body Weights Used in Several Predictive Equations and Indirect Calorimetry Measurements
Indirect calorimetry is the gold standard to measure energy expenditure.
In fact it is not always available and inconstantly feasible.
Various equations for predicting energy expenditure based on body weights have been created.
This study aims at determining the best suitable predictive strategy unless indirect calorimetry is available.
Study Overview
Status
Completed
Conditions
Detailed Description
Several clinical studies have shown that energy deficit as well as overfeeding lead to an increased risk of complications, especially infections, and increased mortality.
The gold standard for determining energy expenditure in intensive care patients is indirect calorimetry.
This method is expensive and requires a trained team for its use.
In addition the reliability of the measurements depends on the clinical situation and may not be feasible (e.g.
inspiratory O2 fraction >60%, end expiratory pressure > 9cmH2O, presence of bronchial gap, etc.).
Moreover, there is no longer on the market valid indirect calorimeter for clinical use in mechanically ventilated patients, and the maintenance of the old valid one (Deltatrac II®) becomes increasingly problematic because the lack of spare parts.
Intensivists have no more choice and use prediction equations for energy expenditure which are based on imprecise anthropometric data (height, weight).
Especially for obese or malnourished patients in the intensive care the body weight represents not a reliable data.
Similarly, secondary water inflation due to metabolic stress and resuscitation complicates the determination of the real body weight.
The difficulty is to know which weight to use in predictive equations.
Due to the paucity in literature on this subject, there is currently no consensus on the reference weight to use in the determination of nutritional needs and medication doses.
So each prescriber calculates the energy target by taking a reference weight based on his own convictions.
This study is part of a quality process of care and practices harmonization, aiming to identify the reference weight to be used and the best suited predictive equation, to predict energy expenditure for patients who cannot benefit from an indirect calorimetry.
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geneva, Switzerland, 1211
- Service of Intensive Care, Geneva University Hospital,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ICU ventilated patients of a tertiary mixed ICU population
Description
Inclusion Criteria:
- Patients admitted to the Geneva ICU
- Length of stay > 72 hours
- Mechanical ventilation with: FiO2 < 60%; positive end expiratory pressure < 9 cmH2O; no air leaks, absence of pulmonary multi-resistant bacteria
- Without mechanical ventilation: no claustrophobia; no oxygen dependence
Exclusion Criteria:
- All patients without inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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All patients
All ICU patients mechanically ventilated staying more than 72 hours were included and indirect calorimetry was performed and compared to predictive energy expenditure formulas using different body weights.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best energy expenditure prediction, compared to indirect calorimetry by Deltatrac II vs. various predictive equations based on different body weights (ideal, anamnestic, actual, and adjusted).
Time Frame: Time frame will be 24 hours; no further follow-up will be done.
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Find the best energy expenditure prediction, by comparing results from an indirect calorimetry measurement using the Deltatrac II (considered the reference method), and various predictive equations based on body weight.
The ideal body weights (calculated for a body mass index at 22.5 and 25 kg/m2, calculated with the Brocca and Lorentz equations and calculated with the Metropolitan Life Insurance tables), the anamnestic body weight (recorded from the patient/his family members or the electronical medical file), the actual body weight (using a built- in bed scale), and adjusted body weight (determined by correcting the measured body weight according to the cumulative fluid balance) will be recorded and used to calculate various predictive energy expenditure.
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Time frame will be 24 hours; no further follow-up will be done.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claudia - Paula Heidegger, MD, University Hospital, Geneva
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (ACTUAL)
November 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
August 25, 2015
First Submitted That Met QC Criteria
September 16, 2015
First Posted (ESTIMATE)
September 17, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
September 17, 2015
Last Update Submitted That Met QC Criteria
September 16, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE:14-070
- 13-18 (OTHER_GRANT: APSI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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