Prevention of DElirium with MELatonine in intensive care unit

Phase 1

• Conditions: patients in intensive care unit with invasive mechanical ventilation; MedDRA version: 20.0 Level: PT Classification code 10012218 Term: Delirium System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-003321-14-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 355

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified