Senior-COVID-Rea Multicentric Survey

NCT ID: NCT04422340

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Disease, Severe Form

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Group1

* Comorbidities (CIRS-G scale),
* Functional status of the patient with

* Clinical frailty scale (1 month before infection)
* ADL score (1 month before infection)
* Biological data

* Blood group
* TP, D-dimers, CRP, creatinine level at the patient's entry, triglyceridemia, fibrinogen, ferritin
* Parameters derived from the platelet formula count on D1 of the start of intensive care (lymphocytes, neutrophils, platelets, average platelet volume, red blood cell distribution index), SYSMEX data (IG: Immature granulocytes; HFLC: high fluorescent lymphocyte count)
* Resuscitation outcomes

* LDH rate at the start of intensive care
* PaO2 / FiO2 ratio at the start of intensive care
* IGSII / SASPII score (simplified acute physiology score) on D1 of the start of intensive care
* SOFA score (sepsis-related organ failure assessment): a posteriori estimate based on IGSII / SASPII
* Delay between the appearance of the first signs of infection and admission to intensive care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Falandry, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Resuscitation unit at Hospital Emile Roux

Le Puy-en-Velay, , France

Site Status RECRUITING

- Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

- Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Service de Réanimation de l'Hôpital Nord Ouest

Villefranche-sur-Saône, , France

Site Status RECRUITING

Medipole Resuscitation unit

Villeurbanne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire Falandry, MD

Role: CONTACT

33 4 78 86 32 87

Facility Contacts

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Claire Falandry, MD

Role: primary

Claire Falandry, MD

Role: primary

Claire Falandry, MD

Role: primary

Claire Falandry, MD

Role: primary

Claire Falandry, MD

Role: primary

Max Haine, MD

Role: primary

Vincent COLLANGE, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35379312 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34230013 (View on PubMed)

Other Identifiers

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69HCL20_0386

Identifier Type: -

Identifier Source: org_study_id

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