Melatonin for Treatment of Delirium in Critically Ill Adult Patients (DELIRE-ICU)
Delirium
About this trial
This is an interventional treatment trial for Delirium focused on measuring Melatonin, Intensive care, Feasibility, Treatment, Critically ill, ICU
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older admitted to the intensive care unit; Anticipated ICU stay > 48 hours; ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization. Exclusion Criteria: Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®; Use of melatonin within 24 hours prior to randomization; Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy; Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal; Presence of active seizures, coma, aphasia or severe intellectual disability; Limited short-term vital prognosis; Diagnosis of delirium prior to ICU admission; Pregnancy or breastfeeding; Absolute contraindication to receive enteral medication; Inability to understand or speak English or French; Total blindness.
Sites / Locations
- Hopital Maisonneuve-RosemontRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Enteral melatonin 9 mg
Enteral placebo
Melatonin 9 mg from a 1 mg/mL oral suspension of melatonin in ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.
ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.