Melatonin for Prevention of Delirium in Critically Ill Patients

• Status: Unknown status
• Trial end date: 2019-10-12
• 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 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.

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

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Hopital du Sacre-Coeur de Montreal; Sunnybrook Health Sciences Centre
• Treatments: Melatonin

Criteria

Inclusion Criteria:

1. Critically ill patients ≥18 years of age

2. Anticipated ICU stay of >48 hours

3. 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)

4. Consent to participate.

Exclusion Criteria:

1. ICU admission of >48 hours prior to screening

2. 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)

3. Screened delirium positive prior to randomization (ICDSC score ≥4 out of 8)

4. Anticipated withdrawal in next 48 hours

5. 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

6. Unable to communicate in English or French (Montreal site)

7. 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)

8. Active seizures

9. Known pregnancy

10. Legal blindness

11. Known allergy to melatonin