Melatonin for prevention of delirium in patients receiving mechanical ventilation in the intensive care unit: a multiarm multistage adaptive randomized controlled clinical trial (DEMEL).

ABSTRACT:

Purpose

To determine the dose of melatonin with an optimal pharmacokinetic profile and to test whether this dose reduces the prevalence of delirium in mechanically ventilated ICU patients as compared to placebo.

Methods

DEMEL, a multicenter adaptive phase 2b/3 randomized, placebo-controlled, double-blind trial included patients at 20 health centers in France from February 1st, 2019 through January 5th, 2021. Patients were randomized (1:1:1) to receive either placebo or low (0.3 mg) or high (3 mg) dose melatonin enterally at 9:00 p.m. for 14 consecutive nights or until death or ICU discharge, whichever came first. The interim primary endpoint (activity stage) was the percentage of patients who achieved an optimal melatonin pharmacokinetic profile 24 h after starting study tre

SUBMITTER: Mekontso Dessap A 

PROVIDER: S-EPMC12283818 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature