ICU sedation, delirium & recovery
Low-Dose Melatonin for Prevention of Delirium in Critically Ill Patients: A Multicenter, Randomized, Placebo-Controlled Feasibility Trial
Authors' conclusion
Our trial protocol comparing 2 low doses of melatonin and placebo for delirium prevention in critically ill adults demonstrated feasibility for protocol adherence.
Study context
- Population
- Adults ≥ 18 years free of delirium at enrollment, anticipated > 48-hour ICU stay, 3 tertiary academic ICUs396 eligible
- Participants
- 71 adults
- Comparison
- Nightly melatonin 0.5 mg or 2 mg vs placebo
- Primary endpoint
- Protocol adherence: ≥ 85% (± 5% margin of error) of drug doses administered as per protocol (primary feasibility target)
Methodological detailsfeasibility trial, 3-arm, placebo-controlled, multicentre
- Feasibility trial
- 3-arm
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
Drug administration protocol adherence per patient
Median adherence (IQR 92.3%-100%)
100%
Mean adherence (SD 24.4%)
88.7%
Protocol violations, no differences between groups
25
Secondary outcomes
Recruitment rate
- Recruitment rate (patients/mo/site)
- 0.8
- Patients screened
- 2,259
- Excluded
- 1,863 (82.5%)
Delirium and subsyndromal delirium · study period
- Delirium
- 14 (20%)
- Subsyndromal delirium
- 25 (36%)
- No differences between study groups
Safety
- No serious adverse effects detected
Original publication
Low-Dose Melatonin for Prevention of Delirium in Critically Ill Patients: A Multicenter, Randomized, Placebo-Controlled Feasibility Trial. Chest. Published 10 January 2025. doi:10.
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