ICU sedation, delirium & recovery
Melatonin for prevention of delirium in patients receiving mechanical ventilation in the intensive care unit: a multiarm multistage adaptive randomized controlled clinical trial (DEMEL)
Primary result · Delirium incidenceResult — go to the resultRelative risk 0.986 95% CI 0.803–1.211Authors' conclusion
This randomized clinical trial found that the low-dose of melatonin (0.3 mg nightly) achieved a better pharmacokinetic profile than the high-dose (3 mg nightly), but did not change the incidence of delirium compared to placebo in mechanically ventilated critically-ill patients.
Study context
- Population
- Mechanically ventilated ICU patients, 20 centres in France, 2019–2021334 in primary analysis
- Participants
- 355 participants
- Comparison
- Low-dose or high-dose enteral melatonin vs placebo nightly
- Primary endpoint
- Delirium (CAM-ICU twice daily) between randomization and day 14 or death or ICU discharge (final primary endpoint, efficacy phase)
- Follow-up
- Day 14
Methodological detailsmultiarm multistage adaptive, phase 2b/3, placebo-controlled, double-blind, multicentre, High-dose arm discontinued after activity stage on Steering Committee recommendation
- Multiarm multistage adaptive
- Phase 2b/3
- Placebo-controlled
- Double-blind
- Multicentre
- High-dose arm discontinued after activity stage on Steering Committee recommendation
Primary result
Delirium incidence
Relative risk
0.986
95% CI 0.803–1.211
Events by treatment group
Low-dose melatonin vs Placebo
RR 0.986 (95% CI 0.803–1.211)
As reported in the abstract
Secondary outcomes
| Outcome | Placebo | Low-dose melatonin | High-dose melatonin |
|---|---|---|---|
| Optimal melatonin pharmacokinetic profile 24 h after start (interim primary endpoint, activity stage)Interim analysis | 0 events | 50% | 24% |
- Optimal melatonin pharmacokinetic profile 24 h after start (interim primary endpoint, activity stage): preplanned analysis in 75 patients
Key secondary outcomes (sleep quality; delirium-, coma- and ventilator-free days at day 28; ICU and hospital LOS; mortality at day 28, in ICU and in hospital; quality of life and PICS at day 90)
- Similar between groups
Original publication
Melatonin for prevention of delirium in patients receiving mechanical ventilation in the intensive care unit: a multiarm multistage adaptive randomized controlled clinical trial (DEMEL). Intensive Care Med. Published 3 July 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →