Dépret, François
,
Farny, Boris
Jeanne, Mathieu
Klouche, Kada
Leclerc, Thomas
Nouette-Gaulain, Karine
Pantet, Olivier
Rémerand, Francis
Roquilly, Antoine
Rousseau, Anne-Françoise
Sztajnic, Simon
Wiramus, Sandrine
Vicaut, Eric
Legrand, Matthieu http://orcid.org/0000-0001-9788-5316
Funding for this research was provided by:
PHRC-N 2018 (PHRCN-18-0529)
Article History
Received: 18 May 2020
Accepted: 12 November 2020
First Online: 25 November 2020
Ethics approval and consent to participate
: This trial will be 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 No. 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 situation 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 in the study. 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 in the research and the collection and exploitation of the data.The study protocol was approved by the institutional review board (IRB) of Sud Est IV on 11 December 2019 (approval number 2019-002396-34), and from the agence nationale de sécurité du medicament et des produits de santé (MEDAECNAT-2019-10-00036), it was registered as a clinical trial on 2 March 2020 (NCT03788837) and in EudraCT (No. 2019-002396-34).
: As clinical images 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.EV declares no conflict of interest.FD received lecture fees from Sedana Medical and Biomerieux and research grant from the French Ministry of Health, European Society of Intensive Care Medicine, and Société Française d’Anesthésie Réanimation.