Prevention of DElirium with MELatonine in intensive care unit : prospective, multicenter, randomized, double-blind, placebo, multi-arm, multi-stage trial. - DEME

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 355 人开始时间: 2018年3月21日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•- Age > = 18 years
•- Patient with invasive mechanical ventilation
•- Anticipated stay in intensive care unit of at least 48 hours
•- Informed consent signed by the patient or a trusted person / family member or lack of consent in the event of a life-threatening emergency
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 55

•- Admission in the intensive care unit for more than 48 hours
•- Pregnancy or breastfeeding
•- No understanding of the French language, deafness
•- Dementia (Mini Mental State <20) or known chronic psychosis
•- Delirium (positive CAM-ICU score) before or at the time of randomization
•- Alcohol withdrawal syndrome with Cushman score >=5 before or at the time of randomization
•- Inability to use the enteral route, food intolerance with vomiting
•- Severe hepatic insufficiency (prothrombin level <30%)
•- Ongoing treatment with melatonin or drugs that interact with or modify its metabolism (fluvoxamine, 5- or 8-methoxypsoralen, estrogen, cimetidine, carbamazepine, rifampicin)
•- Dying patient
•- Patient under tutorship or curatorship
•- Patient deprived of liberty by judicial or administrative decision
•- Patient not affiliated to a social security scheme and not a beneficiary of such a scheme
•- Patient participating in another interventional clinical study with melatonin and / or for whom delirium is the primary endpoint.
•- Allergy known to melatonin
•- Patient admitted to intensive care for a cardiorespiratory arrest, stroke, head trauma, neurosurgery.

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