REmimazolam infusion in the context of Hypnotic Shortage in the Critical care Unit during the pandemic of COVID-19. The non-randomized, non-controlled, pilot, open, mono-centric REHSCU study. - REHSC

CHU de Nantes0 个研究点目标入组 30 人开始时间: 2020年10月1日最近更新: 2020年11月3日

适应症

试验速览

暂无简介。

•PRE-INCLUSION CRITERIA
•- Next-of-kin, Legal representative written informed consent
•- affiliation with French social security system or beneficiary from such system
•INCLUSION CRITERIA
•- Patients at least 18 years old
•- Inclusion in the first 96 hours after ICU admission, after clinical stabilization according to the attending physician’s discretion.
•- Expected duration of general anaesthesia = 24 hours
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•-Patients more than 85 years-old
•-Refusal to participate
•-Severe patients with moribund state within the 24 hours after admission to the ICU
•-Withdrawal of Life Sustaining Therapies within the 24 hours after admission to the ICU
•-Any pregnant or breast-feeding patient,
•-Patients with known anaphylactic reactions to benzodiazepines, flumazenil, or a medical condition such that these agents are contraindicated (according to local label)
•-Patients with allergy/hypersensitivity to bovine lactose, dextran or any other excipient in the remimazolam product
•-Presence of acute alcoholic or illicit drug intoxication or benzodiazepine intoxication
•-Inclusion in another clinical (drug) trial
•-Patient under guardianship or trusteeship
•-Patient under judicial protection
•-Severe hepatic impairment defined as a Child-Pugh score > 10.

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