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

NCT ID: NCT02552446

Last Updated: 2015-09-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 IIĀ®) 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Body Weights

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

HEIDEGGER CP

MD Deputy head physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claudia - Paula Heidegger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service of Intensive Care, Geneva University Hospital,

Geneva, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26653566 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-18

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CE:14-070

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Metabolic Rate in Burns
NCT03024931 UNKNOWN