NCT04391686

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

May 15, 2020

Last Update Submit

March 14, 2022

Conditions

Keywords

resting energy expenditureartificial nutrition

Outcome Measures

Primary Outcomes (1)

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

    baseline and 3 months later

Study Arms (3)

COVID intensive care unit

Diagnostic Test: indirect calorimetry

intensive care unit

Diagnostic Test: indirect calorimetry

obesity

Diagnostic Test: indirect calorimetry

Interventions

indirect calorimetryDIAGNOSTIC_TEST

to determine and compare the resting energy expenditure of each group

COVID intensive care unitintensive care unitobesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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 ;
  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arras general hospital

Arras, 62000, France

Location

MeSH Terms

Conditions

COVID-19Obesity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent FLORENT, MD, PhD

    Centre Hospitalier Arras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 18, 2020

Study Start

July 3, 2020

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations