Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis (RECORDS): study protocol for a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial. Issue 3 (10th March 2023)

• Record Type: Journal Article
• Authors: Fleuriet, Jérôme; Heming, Nicholas; Meziani, Ferhat; Reignier, Jean; Declerq, Pierre-Louis; Mercier, Emmanuelle; Muller, Grégoire; Colin, Gwenhaël; Monnet, Xavier; Robine, Adrien; Siami, Shidasp; Uhel, Fabrice; Quenot, Jean-Pierre; Plantefeve, Gaetan; Badie, Julio; Schneider, Francis; Cerf, Charles; Troché, Gilles; Monchi, Mehran; Mira, Jean-Paul; Francois, Bruno; Chevret, Sylvie; Annane, Djillali
• Other Names: author non-byline.; Antigoni Alexandrou author non-byline.; Djillali Annane author non-byline.; Birte Arlt author non-byline.; Julio Badie author non-byline.; Sarah Benghanem author non-byline.; Fernando Berdaguer Ferrari author non-byline.; Charles Cerf author non-byline.; Zaineb Chelly Dagdia author non-byline.; Sylvie Chevret author non-byline.; Gwenhaël Colin author non-byline.; Christel Daniel author non-byline.; Pierre-Louis Declercq author non-byline.; Agathe Delbove author non-byline.; Philippe Devillier author non-byline.; Jérome Fleuriet author non-byline.; Bruno François author non-byline.; Henri-Jean Garchon author non-byline.; Véronique Godot author non-byline.; Stanislas Grassin-Delyle author non-byline.; Mathieu Grisolia author non-byline.; Christophe Guitton author non-byline.; Julie Helms author non-byline.; Nicholas Heming author non-byline.; Marielle Herzog author non-byline.; Toufik Kamel author non-byline.; Zoubida Kedad author non-byline.; Philippe Lassalle author non-byline.; Guillaume Lhermite author non-byline.; Bruno Megarbane author non-byline.; Armand Mekontso Dessap author non-byline.; Emmanuelle Mercier author non-byline.; Ferhat Meziani author non-byline.; Jean-Paul Mira author non-byline.; Mehran Monchi author non-byline.; Xavier Monnet author non-byline.; Grégoire Muller author non-byline.; Jean-Pierre Quenot author non-byline.; Jean Reignier author non-byline.; Adrien Robine author non-byline.; Martin Rottman author non-byline.; Anne-Laure Roux author non-byline.; Francis Schneider author non-byline.; Shidasp Siami author non-byline.; Pierre Tissieres author non-byline.; Gilles Troché author non-byline.; Fabrice Uhel author non-byline.; Karine Zeitouni author non-byline.; Gaëtan Plantefève author non-byline.; author non-byline.; Bodet-Contentin Laetitia author non-byline.; Darwiche Walid author non-byline.; Ehrmann Stephan author non-byline.; Garot Denis author non-byline.; Guillon Antoine author non-byline.; Jouan Youenn author non-byline.; Legras Annick author non-byline.; Mankikian Julie author non-byline.; Mercier Emmanuelle author non-byline.; Morisseau Marlene author non-byline.; Perez Yonatan author non-byline.; Rouve Emmanuelle author non-byline.; Salmon-Gandonniere Charlotte author non-byline.; Helms Julie author non-byline.; Rahmani Hassene author non-byline.; Monnier Alexandra author non-byline.; Merdji Hamid author non-byline.; Clere-Jehl Raphael author non-byline.; Stiel Laure author non-byline.; Studer Antoine author non-byline.; Andreu Pascal author non-byline.; Roudaut Jean-Baptiste author non-byline.; Labruyere Marie author non-byline.; Jacquier Marine author non-byline.; Barbier Francois author non-byline.; Benzekri Dalila author non-byline.; Boulain Thierry author non-byline.; Jacquier Sophie author non-byline.; Mathonnet Armelle author non-byline.; Muller Gregoire author non-byline.; Nai Mai-Anh author non-byline.; Runge Isabelle author non-byline.; Tollec Sophie author non-byline.; Roux Damien author non-byline.; Messika Jonathan author non-byline.; Vuillard Constance author non-byline.; Dumont Louis-Marie author non-byline.; Federici Laura author non-byline.; Zucman Noemie author non-byline.; Amouretti Marc author non-byline.; Annane Djillali author non-byline.; Moine Pierre author non-byline.; Meng Paris author non-byline.; Bounab Rania author non-byline.; Fartoukh Muriel-Sarah author non-byline.; Djibre Michel author non-byline.; Elabbadi Alexandre author non-byline.; Azais Marie-Ange author non-byline.; Bachoumas Konstantinos author non-byline.; Bailly Arthur author non-byline.; Bernardon Remi author non-byline.; Blonz Gauthier author non-byline.; Desmedt Luc author non-byline.; Emonet Brian author non-byline.; Fiancette Maud author non-byline.; Henry Matthieu author non-byline.; Lacherade Jean-Claude author non-byline.; Lascarrou Jean-Baptiste author non-byline.; Lebert Christine author non-byline.; Lorber Julien author non-byline.; Martin-Lefevre Laurent author non-byline.; Pouplet Caroline author non-byline.; Vinatier Isabelle author non-byline.; Yehia Aihem author non-byline.; Benghanem Sarah author non-byline.; Charpentier Julien author non-byline.; Vigneron Clara author non-byline.; Pichon Nicolas author non-byline.; Fedou Anne-Laure author non-byline.; Mancia Claire author non-byline.; Begot Emmanuelle author non-byline.; Daix Thomas author non-byline.; Vignon Philippe author non-byline.; Galy Antoine author non-byline.; Gonzalez Celine author non-byline.; Goudelin Marine author non-byline.; Evrard Bruno author non-byline.; Desachy Arnaud author non-byline.; Vaidie Julien author non-byline.; Gilbert Guillaume author non-byline.; Darreau Cedric author non-byline.; Derrien Benoit author non-byline.; Saint-Martin Marjorie author non-byline.; Tirot Patrice author non-byline.; Landais Mickael author non-byline.; Chudeau Nicolas author non-byline.; Callahan Jean Christophe author non-byline.; Vivier Dominique author non-byline.; Moal Charlene Le author non-byline.; Olivier Pierre-Yves author non-byline.; Marnai Remy author non-byline.; Schneider Francis author non-byline.; Sedillot Nicolas author non-byline.; Tchenio Xavier author non-byline.; Robine Adrien author non-byline.; Poncelin Yves author non-byline.; Bruyere Remi author non-byline.;
• Is Part Of: BMJ open. Volume 13:Issue 3(2023)
• Publication Date: 2023-03-10
• Subjects: adult intensive & critical care -- clinical trials -- respiratory infections; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-066496
• Languages: English
• ISSNs: 2044-6055

Abstract

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 ).