Melatonin for Prevention of Delirium in Critically Ill Patients (MELLOW-1)
Delirium
About this trial
This is an interventional prevention trial for Delirium focused on measuring delirium, melatonin, pharmacokinetics, feasibility, prevention
Eligibility Criteria
Inclusion Criteria:
- Critically ill patients ≥18 years of age
- Anticipated ICU stay of >48 hours
- Able to receive enteral administration of study drug (i.e. by mouth or any feeding tube = naso- or oro- or percutaneous gastric or post-pyloric feeding tube)
- Consent to participate.
Exclusion Criteria:
- ICU admission of >48 hours prior to screening
- Unable to assess for delirium (e.g. comatose defined as SAS 1 or 2 or either 'No Response' Score A or B on ICDSC, chemically paralyzed with neuromuscular blocking drugs)
- Screened delirium positive prior to randomization (ICDSC score ≥4 out of 8)
- Anticipated withdrawal in next 48 hours
- Known history of severe cognitive or neurodegenerative disease (e.g. dementia, Parkinson's disease) or severe structural brain injury (e.g. traumatic brain injury, intracranial hemorrhage) as the ICDSC assessment tool has not been validated in these patient populations
- Unable to communicate in English or French (Montreal site)
- Contraindications to receiving any enteral medication (defined as absolute contraindication to enteral nutrition such as gastrointestinal obstruction, perforation, recent upper GI surgery, no enteral access)
- Active seizures
- Known pregnancy
- Legal blindness
- Known allergy to melatonin
Sites / Locations
- Mount Sinai HospitalRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- Hôpital du Sacré-Coeur
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Enteral melatonin 0.5 mg
Enteral melatonin 2 mg
Enteral matched placebo
Melatonin 0.5 mg from the 1mg/mL oral suspension qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration of 0.1 mg/mL; final volume in the oral syringe will be 5 mL)
Melatonin 2 mg from the 1mg/mL oral suspension qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration 0.4 mg/mL; final volume in the oral syringe will be 5 mL)
Melatonin 0 mg qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration 0 mg/mL; final volume in the oral syringe will be 5 mL)