COVID-19RECOVERYNCT04391686
Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context
An observational study of COVID-19 and Obesity, run by Centre Hospitalier Arras at 1 site in France.
Trial summary
Compare the resting energy expenditure of COVID-19 patients (obese or non-obese) in intensive care unit with mechanical ventilation to a control group of non-COVID-19 intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- indirect calorimetry
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2020to 4 Nov 2021
- How long will I take part?
- 3 Months
- 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: Patients admitted to resuscitation under mechanical ventilation and who have benefited from a first indirect calorimetry measurement via COSMED Q NRG within 48 hours after their admission are identified by the physicians of the resuscitation department. If these patients meet all the inclusion criteria, they will be notified to the center's investigators so that the latter can take the necessary steps to inform the patient or the confidential person about the study.
Who may be able to join
- For the Ambulatory Obese Control Group, the inclusion criteria are:
- Age ≥ 18 years;
- Patient followed in the nutrition service;
- Patient who benefited from an indirect calorimetry whatever the indication between 01/01/20 and 31/12/2020;
- BMI> 30.
- For the COVID Group and the Resuscitation Control Group, the inclusion criteria are:
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- Age ≥ 18 years;
- Patient having undergone a resuscitation stay
- Patient on mechanical ventilation (intubated or tracheotomized) during their stay in intensive care;
- Patient having benefited from an indirect calorimetry upon arrival in intensive care;
- Only for the COVID Group:
- Patient hospitalized in intensive care for COVID 19 infection diagnosed by a positive PCR via nasopharyngeal sampling or endotracheal aspiration.
- Patient who has not yet carried out his post-resuscitation visit;
- Only for the Resuscitation Control Group:
- Patient hospitalized in intensive care for an indication other than an infectious cause.
Who cannot join
- Non-inclusion criteria for the Ambulatory Obese Control Group:
- Person deprived of liberty;
- Person subject to legal protection measures;
- Patient's opposition to participate in research.
- The non-inclusion criteria for the COVID Group and the Resuscitation Control Group:
- For patients intubated during the resuscitation stay Fi02> 70% which does not allow a correct interpretation of the calorimetry;
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- Pregnancy ;
- Person deprived of liberty;
- Person subject to legal protection measures;
- Opposition of the patient or the person of trust to participate in the research.
- Only for the COVID Group:
- Contraindication to indirect calorimetry (claustrophobia for post-resuscitation patients where calorimetry is performed with a mask);
- Contraindication to bioimpedancemetry (electronic implants, limb amputation, weight <30kg or> 300kg);
Trial locations and contacts
1 site in 1 country.
About this study
Compare the resting energy expenditure of COVID-19 patients (obese or non-obese) in intensive care unit with mechanical ventilation to a control group of non-COVID-19 intensive care patients.
- Being tested
- indirect calorimetry
- Keywords
- resting energy expenditure, artificial nutrition
- Medical subject headings
- COVID-19, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indirect calorimetryDiagnostic test
to determine and compare the resting energy expenditure of each group
| Study group | Role | What they receive |
|---|---|---|
| COVID intensive care unit | Not described Receives: Diagnostic Test: indirect calorimetry | |
| intensive care unit | Not described Receives: Diagnostic Test: indirect calorimetry | |
| obesity | Not described Receives: Diagnostic Test: indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care.
Measured: baseline and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start3 Jul 2020
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Arras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent FLORENT, MD, PhD, Principal investigator, Centre Hospitalier Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391686
- Sponsor's protocol ID
- 2020-04
- Acronym
- RECOVERY
- Status last verified
- Mar 2022
- First submitted
- 15 May 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context
- ClinicalTrials.gov ID
- NCT04391686
- Acronym / sponsor ID
- RECOVERY / 2020-04
- Keywords
- resting energy expenditure, artificial nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier ArrasUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 18 May 2020 (actual)
- 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.
Compare the resting energy expenditure of COVID-19 patients (obese or non-obese) in intensive care unit with mechanical ventilation to a control group of non-COVID-19 intensive care patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID intensive care unit | – | Diagnostic Test: indirect calorimetry |
| intensive care unit | – | Diagnostic Test: indirect calorimetry |
| obesity | – | Diagnostic Test: indirect calorimetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to resuscitation under mechanical ventilation and who have benefited from a first indirect calorimetry measurement via COSMED Q NRG within 48 hours after their admission are identified by the physicians of the resuscitation department. If these patients meet all the inclusion criteria, they will be notified to the center's investigators so that the latter can take the necessary steps to inform the patient or the confidential person about the study.
Key inclusion criteria (15 listed)
- Age ≥ 18 years;
- Patient followed in the nutrition service;
- Patient who benefited from an indirect calorimetry whatever the indication between 01/01/20 and 31/12/2020;
- BMI> 30.
- Age ≥ 18 years;
Key exclusion criteria (13 listed)
- Person deprived of liberty;
- Person subject to legal protection measures;
- Patient's opposition to participate in research.
- For patients intubated during the resuscitation stay Fi02> 70% which does not allow a correct interpretation of the calorimetry;
- Pregnancy ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indirect calorimetryto determine and compare the resting energy expenditure of each group | Diagnostic test | COVID intensive care unit, intensive care unit, obesity |
Primary outcome
The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care.
Time frame: baseline and 3 months later
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 15 Mar 2022.
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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.
Vincent FLORENT, MD, PhD principal investigator
Centre Hospitalier Arras
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 COVID-19 and Obesity, run by Centre Hospitalier Arras at 1 site in France.
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 15 inclusion and 13 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 15 Mar 2022. 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 France. 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?
The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care. (time frame: baseline and 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.