Louis, Clémence
,
Godet, Thomas
Chanques, Gérald
Bourguignon, Nathalie
Morand, Dominique
Pereira, Bruno
Constantin, Jean-Michel
Funding for this research was provided by:
Centre Hospitalier Universitaire de Clermont-Ferrand
AZUREA Network
Article History
Received: 21 November 2017
Accepted: 28 April 2018
First Online: 4 June 2018
Ethics approval and consent to participate
: Due to the specific medical condition of recruited patients (agitated delirium), an emergency inclusion procedure will be possible. Written pursuit consent will be obtained from all participants (once the medical condition has resolved) or their next-of-kin. The Institutional Review Board of the University Hospital of Clermont-Ferrand (France) approved the trial. By 7 June 2017, the study had been approved for all centers by a central ethics committee (Comité de Protection des Personnes Sud-Est V, Grenoble, France, 17-CHCF-02) with the registration number EudraCT 2017–000731-14. Any further additional important protocol modification will require the approval of a central ethics committee (Comité de Protection des Personnes Sud-Est V, Grenoble, France, 17-CHCF-02). The 4D trial was registered on 23 October 2017 at ExternalRef removed with trial identification number NCT 03317067.
: JMC received consulting fees from Baxter.TG reports receiving lecture fees and support for meeting (travel reimbursement) from Baxter Gambro.The remaining authors declare that they have no competing interests.
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