Clinical trial NCT02552446: Energy Expenditure in ICU Patients Using Predictive Formulas and Various Body Weights Versus Indirect Calorimetry
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Body Weights
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU ventilated patients of a tertiary mixed ICU population

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Time frame will be 24 hours; no further follow-up will be done.
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service of Intensive Care, Geneva University Hospital,
Study officials:
affiliation: University Hospital, Geneva
name: Claudia - Paula Heidegger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graf S, Pichard C, Genton L, Oshima T, Heidegger CP. Energy expenditure in mechanically ventilated patients: The weight of body weight! Clin Nutr. 2017 Feb;36(1):224-228. doi: 10.1016/j.clnu.2015.11.007. Epub 2015 Nov 26.