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

Obesity Clinical Trial

— RECOVERY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391686
• Other study ID #: 2020-04
• Status: Completed
• Start date: July 3, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Arras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• COVID-19
• Obesity

Intervention

Diagnostic Test:
• indirect calorimetry
to determine and compare the resting energy expenditure of each group

Locations

Country	Name	City	State
France	Arras general hospital	Arras

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Arras

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care.		baseline and 3 months later