Legrand, Matthieu http://orcid.org/0000-0001-9788-5316
Oufella, Hafid Ait
De Backer, Daniel
Duranteau, Jacques
Leone, Marc
Levy, Bruno
Rossignol, Patrick
Vicaut, Eric
Dépret, François
Depret, François
Constantin, Jean-Michel
Ait Oufella, Hafid
De Backer, Daniel
Levy, Bruno
Leone, Marc
Dureanteau, Jacques
Gaugain, Samuel
Audart, Jules
Lefrant, Jean-Yves
Megarbane, Bruno
Pottecher, Julien
Sonneville, Romain
Rimmele, Thomas
Ichai, Carole
Vieillard, Antoine
Tran Dinh, Alexy
Aubron, Cécile
Mari, Arnaud
Labbe, Vincent
Plantefeve, Gaetan
Fedou, Anne Laure
Barraud, Damien
Gaudry, Stéphane
Nougue, Helene
,
Funding for this research was provided by:
PHRC-2017
Article History
Received: 3 April 2020
Accepted: 22 June 2020
First Online: 1 July 2020
Ethics approval and consent to participate
: This trial is conducted in patients who are potentially unable to consent. Therefore, patients can be included under the emergency provisions of the law (Article L1122-1-3 of the PHC/Order N° 2016-800 of June 16, 2016 - art. 2). Obviously, given the inclusion and non-inclusion criteria, the consent of patients or relatives, if present, cannot be collected at baseline. Thus, given the extreme emergency not allowing collecting the prior consent of the person or relative, the protocol provides that their consent is not necessary. In case of successful resuscitation, delayed consent will be asked to the patient for further participation. The participant shall be informed regarding the study during his or her hospitalization as soon as his or her condition allows. Thereafter, if the patient agrees, he or she signs the delayed consent form to pursue his or her participation in the research, and a “no objection to the use of his/her data” form for the possible continuation of this research will be completed.According to the law (art. L1122-2 and L1121-8 of the Public Health Code), if the patient has a legal representative (guardian designated by law), it belongs to the patient’s guardian to give his or her consent for further participation to the research and the collection and the exploitation of the data.The study protocol was approved by the institutional review board (IRB) of Sud-Est V on October 30, 2018 (approval number 2018-001709-10) and from the Agence Nationale de Sécurité du Medicament et des Produits de santé (MEDAECNAT-2018-07-00015) and was registered in the clinical trial on December 28, 2018 (NCT03788837) and in EudraCT (N° 2018-001709-10).
: As a clinical image or other clinical and personal data are not shown, consent for publication is not applicable.
: ML reports consulting fees from Novartis, lecture fees from Baxter and Fresenius, and research support from Shingotec.HAO declares no conflict of interestDDB is a consultant to and material for studies by Edwards Lifesciences.ML declares COIs with Amomed (consulting, lecture), Aguettant (consulting), MSD (consulting, lecture), Pfizer (lecture), Aspen (lecture), Orion (lecture), and Octapharma (lecture).BL is a member of an advisory board working for Orion Pharma and has received honoraria from the company for his participation in the board and for giving invited lectures at industry symposia.PR is a co-founder of CardioRenal and declares personal fees (consulting) from Novartis, NovoNordisk, Relypsa, AstraZeneca, Grünenthal, Idorsia, Stealth Peptides, Fresenius, Vifor Fresenius Medical Care Renal Pharma, Vifor, and Clinical Trials Mobile Application, and lecture fees from Bayer and CVRx.EV declares no conflict of interest.FD received lecture fees from Sedana medical, a research grant from the French ministry of health.