NCT03524937View on ClinicalTrials.gov

Prevention of Delirium in Intensive Care by Melatonin

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

May 1, 2021

Study Completion Date

May 20, 2021

Conditions
Mechanically Ventilated Patients
Interventions
DRUG

MELATONIN (HIGH DOSE)

Enteral melatonin (3mg) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

DRUG

MELATONIN (LOW DOSE)

Enteral melatonin (0.3mg ) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

DRUG

PLACEBO

Study drug will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days.

Trial Locations (1)

94000

Henri-Mondor Hospital, Créteil

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03524937 - Prevention of Delirium in Intensive Care by Melatonin | Biotech Hunter | Biotech Hunter