drugset / Trial / NCT02615340
Melatonin for Prevention of Delirium in Critically Ill Patients
Phase 2
Unknown
69 enrolled
Mount Sinai Hospital, Canada
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · collabSunnybrook Health Sciences Centre · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for prevention of delirium in critically ill adult patients. The investigators hypothesize that melatonin, administered on a scheduled nightly basis during ICU admission, will be efficacious and safe for the prevention of delirium in critically ill adults.
Timeline
- Start
- 2017-10-12
- Primary completion
- 2018-10-12
- Completion
- 2019-10-12
Publications
- Burry LD, Williamson DR, Detsky ME, Bernard F, Foster J, Mehta S, Pinto R, Scales DC, Rose L. Low-Dose Melatonin for Prevention of Delirium in Critically Ill Patients: A Multicenter, Randomized, Placebo-Controlled Feasibility Trial. Chest. 2025 May;167(5):1397-1407. doi: 10.1016/j.chest.2024.12.030. Epub 2025 Jan 10.
- Burry L, Scales D, Williamson D, Foster J, Mehta S, Guenette M, Fan E, Detsky M, Azad A, Bernard F, Rose L. Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study. BMJ Open. 2017 Mar 30;7(3):e015420. doi: 10.1136/bmjopen-2016-015420.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 0.5 mg | Oral |
| Comparator | Melatonin | Small molecule | 2 mg | Oral |