Status:
RECRUITING
The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
Lead Sponsor:
Sultan Qaboos University
Conditions:
Delirium
Eligibility:
All Genders
65+ years
Phase:
PHASE2
PHASE3
Brief Summary
The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored ...
Detailed Description
Background and rationale: Delirium, a neuropsychiatric syndrome, manifests acutely with altered consciousness, cognitive impairment, and inattention, showing a fluctuating course.1 Delirium can prese...
Eligibility Criteria
Inclusion
- Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
Exclusion
- Patients admitted to the ward, however meeting requirement for vasopressors or non-invasive ventilation.
- Patient admitted through emergency to Intensive Care Unit (ICU) or High Dependency Unit (HDU).
- Aphasic patients.
- Patients with language barriers.
- Already taking melatonin or ramelteon at the time of randomization.
- Presence of delirium at the time of randomization.
- If enteral medications are contraindicated due to gastrointestinal conditions.
- If enteral medications are not allowed due to unavailability of nasogastric tube
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (liver function tests) \> 3 times the upper limit of normal.
- Patient on strong cytochrome P450 1A2 (CYP1A2) inhibitors (namely: fluvoxamine and viloxazine) .
- Patient with active alcohol drinking or admitted with alcohol withdrawal syndrome.
- Subject or proxy unable to provide informed consent within 24 hours of admission.
- Patients with the following autoimmune diseases (Rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythematosus).
- Allergy to melatonin.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06509191
Start Date
September 30 2024
End Date
June 1 2025
Last Update
January 14 2025
Active Locations (2)
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1
Sultan Qaboos University Hospital
Muscat, Oman, 123
2
Sultan Qaboos University Hospital
Muscat, Oman, 123