Critical IllnessNCT02552446
Energy Expenditure in ICU Patients Using Predictive Formulas and Various Body Weights Versus Indirect Calorimetry
An observational study of Critical Illness and Body Weights, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Body Weights
- How many people
- 87 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU ventilated patients of a tertiary mixed ICU population
Who may be able to join
- 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
Who cannot join
- All patients without inclusion criteria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service of Intensive Care, Geneva University Hospital,
Geneva, 1211
About this study
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
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.
Read the 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.
- Conditions
- Critical Illness, Body Weights
- Medical subject headings
- Critical Illness, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time frame will be 24 hours; no further follow-up will be done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HEIDEGGER CP, University Hospital, Geneva
- Investigators
- Claudia - Paula Heidegger, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552446
- Sponsor's protocol ID
- CE:14-070
- Other IDs
- 13-18
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26653566
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02552446
- Acronym / sponsor ID
- CE:14-070
- Conditions
- Critical Illness, Body Weights
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU ventilated patients of a tertiary mixed ICU population
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- All patients without inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Derived from this study: PubMed 26653566Graf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia - Paula Heidegger, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Body Weights, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Time frame will be 24 hours; no further follow-up will be done.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.