Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context (RECOVERY)

March 14, 2022 updated by: Centre Hospitalier Arras
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

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

  • France
      • Arras, France, 62000
        • Arras General 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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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:

  • 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.

Exclusion Criteria:

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;
  • 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);

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obesity
Diagnostic test: indirect calorimetry
to determine and compare the resting energy expenditure of each group
COVID intensive care unit
Diagnostic test: indirect calorimetry
to determine and compare the resting energy expenditure of each group
intensive care unit
Diagnostic test: indirect calorimetry
to determine and compare the resting energy expenditure of each group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care.
Time Frame: baseline and 3 months later
baseline and 3 months later

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Arras

Investigators

  • Principal Investigator: Vincent FLORENT, MD, PhD, Centre Hospitalier Arras

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 (Actual)

July 3, 2020

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on COVID-19

Clinical Trials on indirect calorimetry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe