1. Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis (RECORDS): study protocol for a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial
- Author
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Shidasp Siami, Charlène Le Moal, Thomas DAIX, Sylvie Chevret, Yonatan Perez, Constance Vuillard, Damien Roux, Jonathan Messika, Stephan Ehrmann, Jean-Pierre Quenot, Dalila Benzekri, Gwenhaël Colin, Thierry Boulain, Julie Mankikian, Laura Federici, Jean Reignier, Jean-Paul Mira, Marie-Ange Azais, Djillali Annane, Jean-Claude Lacherade, Grégoire Muller, Christine Lebert, Nicholas Heming, Arthur Bailly, Emmanuelle Mercier, Jean-Baptiste Lascarrou, Julio Badie, Louis-Marie Dumont, Gaetan Plantefeve, Francis Schneider, Patrice Tirot, Isabelle Vinatier, Mickael Landais, Michel Djibré, Bruno Francois, Alexandra Monnier, Francois Barbier, Ferhat Meziani, Hamid Merdji, Pascal Andreu, Julie Helms, Laetitia Bodet-Contentin, Nicolas Pichon, Noémie Zucman, Mehran Monchi, Xavier Monnet, Marie Labruyère, Denis Garot, Hassène Rahmani, Jérôme Fleuriet, Pierre-Louis Declerq, Adrien Robine, Fabrice Uhel, Charles Cerf, Gilles Troché, Alexandrou Antigoni, Annane Djillali, Arlt Birte, Badie Julio, Benghanem Sarah, Berdaguer Ferrari Fernando, Cerf Charles, Chelly Dagdia Zaineb, Chevret Sylvie, Colin Gwenhaël, Daniel Christel, Declercq Pierre-Louis, Delbove Agathe, Devillier Philippe, Fleuriet Jérome, François Bruno, Garchon Henri-Jean, Godot Véronique, Grassin-Delyle Stanislas, Grisolia Mathieu, Guitton Christophe, Helms Julie, Heming Nicholas, Herzog Marielle, Kamel Toufik, Kedad Zoubida, Lassalle Philippe, Lhermite Guillaume, Megarbane Bruno, Mekontso Dessap Armand, Mercier Emmanuelle, Meziani Ferhat, Mira Jean-Paul, Monchi Mehran, Monnet Xavier, Muller Grégoire, Quenot Jean-Pierre, Reignier Jean, Robine Adrien, Rottman Martin, Roux Anne-Laure, Schneider Francis, Siami Shidasp, Tissieres Pierre, Troché Gilles, Uhel Fabrice, Zeitouni Karine, Plantefève Gaëtan, Walid Darwiche, Antoine Guillon, Youenn Jouan, Annick Legras, Marlene Morisseau, Emmanuelle Rouve, Charlotte Salmon-Gandonniere, Raphael Clere-Jehl, Laure Stiel, Antoine Studer, Jean-Baptiste Roudaut, Marine Jacquier, Sophie Jacquier, Armelle Mathonnet, Mai-Anh Nai, Isabelle Runge, Sophie Tollec, Marc Amouretti, Pierre Moine, Paris Meng, Rania Bounab, Muriel-Sarah Fartoukh, Alexandre Elabbadi, Konstantinos Bachoumas, Remi Bernardon, Gauthier Blonz, Luc Desmedt, Brian Emonet, Maud Fiancette, Matthieu Henry, Julien Lorber, Laurent Martin-Lefevre, Caroline Pouplet, Aihem Yehia, Sarah Benghanem, Julien Charpentier, Clara Vigneron, Anne-Laure Fedou, Claire Mancia, Emmanuelle Begot, Philippe Vignon, Antoine Galy, Celine Gonzalez, Marine Goudelin, Bruno Evrard, Arnaud Desachy, Julien Vaidie, Guillaume Gilbert, Cedric Darreau, Benoit Derrien, Marjorie Saint-Martin, Nicolas Chudeau, Jean Christophe Callahan, Dominique Vivier, Pierre-Yves Olivier, Remy Marnai, Nicolas Sedillot, Xavier Tchenio, Yves Poncelin, Remi Bruyere, Grimaldi Lamiae, and Derridj Nawal
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Medicine - Abstract
Introduction Corticosteroids affect variably survival in sepsis trials, suggesting heterogeneity in patients’ response to corticosteroids. The RECORDS (Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis) trial aimed at defining endotypes associated with adults with sepsis responsiveness to corticosteroids.Methods and analysis RECORDS, a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial, will randomly assign to a biomarker stratum 1800 adults with community-acquired pneumonia, vasopressor-dependent sepsis, septic shock or acute respiratory distress syndrome. In each stratum, patients will be randomly assigned to receive a 7-day course of hydrocortisone and fludrocortisone or their placebos. Patients with COVID-19 will be treated with a 10-day standard course of dexamethasone and randomised to fludrocortisone or its placebo. Primary outcome will be 90-day death or persistent organ dysfunction. Large simulation study will be performed across a range of plausible scenarios to foresee power to detect a 5%–10% absolute difference with corticosteroids. We will assess subset-by-treatment interaction by estimating in a Bayesian framework two quantities: (1) measure of influence, relying on the value of the estimation of corticosteroids’ effect in each subset, and (2) measure of interaction.Ethics and dissemination The protocol was approved by the Ethics Committee (Comité de Protection des Personnes, Dijon, France), on 6 April 2020. Trial results will be disseminated at scientific conferences and results will be published in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT04280497).
- Published
- 2023
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