Clinical trial NCT04422340: Senior-COVID-Rea Multicentric Survey
Official title: A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Disease, Severe Form
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 185
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 60 in intensive care unit for severe COVID infection

Brief summary: With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care.

However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy.

Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified.

The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* Patient over 60
* sent to the intensive care unit
* whose COVID diagnosis has been established (RT-PCR and / or chest scanner)

Exclusion Criteria:

* Refusal of the patient or his support person to participate in the study

Primary outcomes:
measure: Evaluation of the impact of age on mortality at 30 days after admission to intensive care
timeFrame: 30 days after resuscitation admission
Secondary outcomes:
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Resuscitation unit at Hospital Emile Roux
city: Lyon
country: France
facility: - Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon
city: Lyon
country: France
facility: - Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon
city: Lyon
country: France
facility: Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon
city: Lyon
country: France
facility: Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon
city: Villefranche-sur-Saône
country: France
facility: Service de Réanimation de l'Hôpital Nord Ouest
city: Villeurbanne
country: France
facility: Medipole Resuscitation unit
Study officials:
affiliation: Hospices Civils de Lyon
name: Claire Falandry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiolliere F, Falandry C, Allaouchiche B, Geoffray V, Bitker L, Reignier J, Abraham P, Malaquin S, Balanca B, Boyer H, Seguin P, Guichon C, Simon M, Friggeri A, Vacheron CH; AZUREA Study Group. Intensive care-related loss of quality of life and autonomy at 6 months post-discharge: Does COVID-19 really make things worse? Crit Care. 2022 Apr 4;26(1):94. doi: 10.1186/s13054-022-03958-6.
citation: Falandry C, Malapert A, Roche M, Subtil F, Berthiller J, Boin C, Dubreuil J, Ravot C, Bitker L, Abraham P, Collange V, Balanca B, Goutte S, Guichon C, Gadea E, Argaud L, Dayde D, Jallades L, Lepape A, Pialat JB, Friggeri A, Thiolliere F; Senior-COVID-Rea study Group. Risk factors associated with day-30 mortality in patients over 60 years old admitted in ICU for severe COVID-19: the Senior-COVID-Rea Multicentre Survey protocol. BMJ Open. 2021 Jul 6;11(7):e044449. doi: 10.1136/bmjopen-2020-044449.