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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: patients in intensive care unit with invasive mechanical ventilation
Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment: 355
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

March 21, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\- 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