Melatonin for Treatment of Delirium in Critically Ill Adult Patients

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, we believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborator: Maisonneuve-Rosemont Hospital
• Treatments: Melatonin

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.