Article (Scientific journals)
Multicentre observational status-epilepticus registry: protocol for ICTAL.
Jacq, Gwenaelle; Chelly, Jonathan; Quenot, Jean-Pierre et al.
2022In BMJ Open, 12 (2), p. 059675
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2022 BMJ Open - Jacq - Multicentre observational status- epilepticus registry- protocol for ICTAL.pdf
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Keywords :
adult intensive & critical care; adult neurology; epidemiology; Critical Care/methods; Cross-Sectional Studies; Humans; Multicenter Studies as Topic; Registries; Retrospective Studies; Status Epilepticus/epidemiology; Status Epilepticus/therapy; Critical Care; Status Epilepticus; Medicine (all); General Medicine
Abstract :
[en] ("[en] INTRODUCTION: Status epilepticus (SE) is a common life-threatening neurological emergency that can cause long-term impairments. Overall outcomes remain poor. Major efforts are required to clarify the epidemiology of SE and the determinants of outcomes, thereby identifying targets for improved management. METHODS AND ANALYSIS: ICTAL Registry is a multicentre open cohort of critically ill patients with convulsive, non-convulsive or psychogenic non-epileptic SE. Observational methods are applied to collect uniform data. The goal of the ICTAL Registry is to collect high-quality information on a large number of patients, thereby allowing elucidation of the pathophysiological mechanisms involved in mortality and morbidity. The registry structure is modular, with a large core data set and the opportunity for research teams to create satellite data sets for observational or interventional studies (eg, cohort multiple randomised controlled trials, cross-sectional studies and short-term and long-term longitudinal outcome studies). The availability of core data will hasten patient recruitment to studies, while also decreasing costs. Importantly, the vast amount of data from a large number of patients will allow valid subgroup analyses, which are expected to identify patient populations requiring specific treatment strategies. The results of the studies will have a broad spectrum of application, particularly given the multidisciplinary approach used by the IctalGroup research network. ETHICS AND DISSEMINATION: The ICTAL Registry protocol was approved by the ethics committee of the French Intensive Care Society (#CE_SRLF 19-68 and 19-68a). Patients or their relatives/proxies received written information to the use of the retrospectively collected and pseudonymised data, in compliance with French law. Prospectively included patients receive written consent form as soon as they recover decision-making competency; if they refuse consent, they are excluded from the registry. Data from the registry will be disseminated via conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03457831.","[en] ","")
Disciplines :
Anesthesia & intensive care
Author, co-author :
Jacq, Gwenaelle;  Service de réanimation et unité de soins continus, Centre Hospitalier de Versailles, Le Chesnay, France
Chelly, Jonathan ;  Service de réanimation, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer, Toulon, France
Quenot, Jean-Pierre ;  Réanimation médicale, CHU Dijon, Dijon, France
Soulier, Pauline;  Service de réanimation, Groupe Hospitalier Sud Ile-de-France, Melun, France
Lesieur, Olivier;  Service de réanimation, Centre hospitalier de la Rochelle, La Rochelle, Nouvelle-Aquitaine, France
Beuret, Pascal;  Service de Réanimation et Soins Continus, Centre Hospitalier de Roanne, Roanne, Rhône-Alpes, France
Holleville, Mathilde;  Department of Anesthesiology and Critical Care, AP-HP, Paris, Nord, France
Bruel, Cedric;  Service de réanimation, Groupe hospitalier Paris Saint Joseph, Paris, France
Bailly, Pierre ;  Médecine Intensive Réanimation, CHU de Brest, Brest, France
Sauneuf, Bertrand;  Service de réanimation, Centre Hospitalier Louis Pasteur de Cherbourg, Cherbourg-Octeville, Basse-Normandie, France
Sejourne, Caroline;  Service de réanimation, Hôpital de Béthune, Beuvry, France
Rigaud, Jean Philippe;  Service de réanimation, Centre Hospitalier de Dieppe, Dieppe, Haute-Normandie, France
Galbois, Arnaud;  Intensive Care Unit, Claude Galien Private Hospital, Quincy-sous-Senart, Île-de-France, France
Arrayago, Marine;  Department of Intensive Care, Cannes Hospital, Cannes, France
Plantefeve, Gaetan;  Service de Médecine Intensive Réanimation, Centre Hospitalier d'Argenteuil, Argenteuil, Île-de-France, France
Stoclin, Annabelle;  Service de réanimation, Instituy Gustave Roussy, Villejuif, France
Schnell, David;  Service de réanimation, Hospital Centre Angouleme, Angouleme, Poitou-Charentes, France
Fontaine, Candice;  Service de réanimation et unité de soins continus, Centre Hospitalier de Versailles, Le Chesnay, France
Perier, François;  Service de réanimation et unité de soins continus, Centre Hospitalier de Versailles, Le Chesnay, France
Bougouin, Wulfran;  Intensive Care Unit, Jacques Cartier Private Hospital, Massy, France
Pichon, Nicolas;  Service de réanimation, Centre Hospitalier de Brive, Brive-la-Gaillarde, France
Mongardon, Nicolas;  Service de Médecine Intensive-Réanimation, Hôpital Henri Mondor, Creteil, Île-de-France, France
Ledoux, Didier  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service des soins intensifs
Lascarrou, Jean-Baptiste;  Service de Médecine Intensive Réanimation, CHU Nantes, Nantes, Pays de la Loire, France
Legriel, Stephane ;  Service de réanimation et unité de soins continus, Centre Hospitalier de Versailles, Le Chesnay, France ; University Paris-Saclay, UVSQ, INSERM, Team « PsyDev », CESP, Villejuif, France
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Language :
Title :
Multicentre observational status-epilepticus registry: protocol for ICTAL.
Publication date :
15 February 2022
Journal title :
BMJ Open
Publisher :
BMJ Publishing Group, England
Volume :
Issue :
Pages :
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
Délégation à la Recherche Clinique et à l’Innovation (DRCI), Versailles, France
Funding text :
Acknowledgements We thank A Wolfe MD (Chaumont, France) for helping to prepare the manuscript. The study was supported by the French public funding agency Délégation à la Recherche Clinique et à l’Innovation (DRCI), Versailles, France.
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