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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Switzerland
      • Geneva, Switzerland, 1211
        • Service of Intensive Care, Geneva University Hospital,

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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