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OpenTrials
Completed

NCT Number: NCT04391686

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

indirect calorimetry

Diagnostic Test

to determine and compare the resting energy expenditure of each group

Primary outcomes

  1. The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care.

    Time frame: baseline and 3 months later

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Arras

Other

Registry information

Acronym: RECOVERY

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 18, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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