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.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
06 07 2021
Historique:
entrez: 7 7 2021
pubmed: 8 7 2021
medline: 10 7 2021
Statut: epublish

Résumé

With the spread of COVID-19 epidemic, health plans must be adapted continuously. There is an urgent need to define the best care courses of patients with COVID-19, especially in intensive care units (ICUs), according to their individualised benefit/risk ratio. Since older age is associated with poorer short-term and long-term outcomes, prediction models are needed, that may assist clinicians in their ICU admission decision. Senior-COVID-Rea was designed to evaluate, in patients over 60 years old admitted in ICU for severe COVID-19 disease, the impact of age and geriatric and paraclinical parameters on their mortality 30 days after ICU admission. This is a multicentre survey protocol to be conducted in seven hospitals of the Auvergne-Rhône-Alpes region, France. All patients over 60 years old admitted in ICU for severe COVID-19 infection (or their legally acceptable representative) will be proposed to enter the study and to fill in a questionnaire regarding their functional and nutritional parameters 1 month before COVID-19 infection. Paraclinical parameters at ICU admission will be collected: lymphocytes and neutrophils counts, high-fluorescent lymphoid cells and immature granulocytes percentages (Sysmex data), D-dimers, C-reactive protein, lactate dehydrogenase (LDH), creatinine, CT scan for lung extension rate as well as clinical resuscitation scores, and the delay between the first signs of infection and ICU admission. The primary outcome will be the overall survival at day 30 post-ICU admission. The analysis of factors predicting mortality at day 30 will be carried out using univariate and multivariate logistic regressions. Multivariate logistic regression will consider up to 15 factors.The ambition of this trial, which takes into account the different approaches of geriatric vulnerability, is to define the respective abilities of different operational criteria of frailty to predict patients' outcomes. The study protocol was ethically approved. The results of the primary and secondary objectives will be published in peer-reviewed journals. NCT04422340.

Identifiants

pubmed: 34230013
pii: bmjopen-2020-044449
doi: 10.1136/bmjopen-2020-044449
pmc: PMC8264162
doi:

Substances chimiques

PHB2 protein, human 0
Prohibitins 0

Banques de données

ClinicalTrials.gov
['NCT04422340']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e044449

Investigateurs

Christophe Leroy (C)
Anne-Claire Lukaszewicz (AC)
Thomas Rimmelé (T)
Marie Simon (M)
Charles-Hervé Vacheron (CH)
Hodane Yonis (H)
Antoine Garnier-Crussard (A)
Max Haïne (M)
Loredana Baboi (L)
Camille Boin (C)
Valérie Cerro (V)
David Dayde (D)
Justine Dubreuil (J)
Carlos El Khoury (CE)
Emilie Gadéa-Deschamps (E)
Marie-Catherine Fromont (MC)
Audrey Gelot (A)
Anthéa Loïez (A)
Amélie Malapert (A)
Céline Monard (C)
Maya Perrou (M)
Laetitia Paradisi-Prieur (L)
Marion Provent (M)
Mélanie Roche (M)
Gulsum Sahin (G)
Ghyslaine Thao (G)
Marine Thieux (M)

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Claire Falandry (C)

Service de Gériatrie, Centre Hospitaliser Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France claire.falandry@chu-lyon.fr.
Laboratoire CarMeN, Inserm U1060, INRA U1397, Université Claude Bernard Lyon 1, INSA Lyon, Faculté de Médecine et de Maïeutique Charles Mérieux, Université de Lyon, Oullins, France.

Amélie Malapert (A)

Plateforme Transversale de Recherche de l'ICHCL, C, Hospices Civils de Lyon, Pierre-Bénite, France.

Mélanie Roche (M)

Plateforme Transversale de Recherche de l'ICHCL, C, Hospices Civils de Lyon, Pierre-Bénite, France.

Fabien Subtil (F)

CNRS UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Université Claude Bernard Lyon 1, Université de Lyon, Villeurbanne, France.
Service de Biostatistique, Hospices Civils de Lyon, Lyon, France.

Julien Berthiller (J)

Université Claude Bernard Lyon 1 - Domaine de Rockefeller, Lyon, France.
SREC - PSP - Cellule innovation, Hospices Civils de Lyon, Bron, France.

Camille Boin (C)

DRCI, Hospices Civils de Lyon, Lyon, France.

Justine Dubreuil (J)

Plateforme Transversale de Recherche de l'ICHCL - Groupement Hospitalier Sud, Hospices Civils de Lyon, Pierre-Bénite, France.

Christine Ravot (C)

Service de Gériatrie, Centre Hospitaliser Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.

Laurent Bitker (L)

Service de Réanimation Médicale, Hôpital de La Croix Rousse, Hospices Civils de Lyon, Lyon, France.
CREATIS INSERM 1044 CNRS 5220, Université de Lyon, Lyon, France.

Paul Abraham (P)

Département d'anesthésie-réanimation, Hôpital Edouard-Herriot, Hospices Civils de Lyon, Lyon, France.

Vincent Collange (V)

Département Anesthésie-réanimation, Medipôle Lyon-Villeurbanne, Villeurbanne, France.

Baptiste Balança (B)

Département d'anesthésie et réanimation neurologique, Hôpital Pierre Wertheimer, Hospices Civils de Lyon, Lyon, France.
Inserm U1028, CNRS UMR 5292, Lyon Neuroscience Research Centre, Team TIGER, University of Lyon, Lyon, France.

Sylvie Goutte (S)

Service de gériatrie, Hôpital Nord-Ouest, Gleizé, France.

Céline Guichon (C)

Service d'anesthésie - réanimation, Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France.
Université Lyon 1, Université de Lyon, Lyon, France.

Emilie Gadea (E)

Département de Recherche Clinique, Centre Hospitalier Emile Roux, Le Puy en Velay, France.

Laurent Argaud (L)

Faculté de médecine Lyon-Est, Université Claude Bernard Lyon 1, Université de Lyon, Lyon, France.
Service de Médecine Intensive-Réanimation Médicale, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.

David Dayde (D)

Plateforme Transversale de Recherche de l'ICHCL, C, Hospices Civils de Lyon, Pierre-Bénite, France.

Laurent Jallades (L)

Service d'Hématologie biologique - Groupement Hospitalier Sud, Hospices Civils de Lyon, Pierre-Bénite, France.

Alain Lepape (A)

Intensive Care Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.
Centre International de Recherche en Infectiologie, Université de Lyon, Lyon, France.

Jean-Baptiste Pialat (JB)

Département de Radiologie, Groupement Hospitalier Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
CREATIS CNRS UMR 5220 INSERM U1206, Université de Lyon, Lyon, France.

Arnaud Friggeri (A)

Intensive Care Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.

Fabrice Thiollière (F)

Intensive Care Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.

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