Energy Expenditure in ICU Patients Using Predictive Formulas and Various Body Weights Versus Indirect Calorimetry

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552446
• Other study ID #: CE:14-070
• Secondary ID: 13-18
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: September 16, 2015
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Body Weights
• Critical Illness

Locations

Country	Name	City	State
Switzerland	Service of Intensive Care, Geneva University Hospital,	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	Time frame will be 24 hours; no further follow-up will be done.	No