Health Condition 1: F05- Delirium due to known physiological condition
Conditions
Interventions
Intervention1: Melatonin: Oral/enteral melatonin 1 mg administered once daily at night (21:00 hrs) via oral or nasogastric route for a maximum duration of 14 consecutive days or until ICU discharge, w
Sponsors
AIIMS JODHPUR
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 to 75 years admitted to the intensive care unit with an expected ICU stay of at least 48 hours. Patients with Richmond Agitation Sedation Scale score of minus 3 or higher indicating arousable to voice. Patients able to receive enteral medication via oral or nasogastric route. Informed consent obtained from patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to melatonin, Severe hepatic failure (Child-Pugh C) ,Pre-existing cognitive impairment or dementia, Active psychiatric illness requiring antipsychotics Patients on chronic melatonin therapy prior to ICU admission ,Deep coma (RASS minus 4 or minus 5) Pregnancy or lactation,Autoimmune and chronic inflammatrory disorder,Refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum IL-6 levels from baseline to Day 7 and Day 14 (or ICU discharge.Timepoint: Change in serum IL-6 levels from baseline to Day 7 and Day 14 (or ICU discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ICU delirium (CAM-ICU) ,Duration of delirium,ICU length of stay Ventilator-free days,28-day mortality Adverse events (sedation, bradycardia, hypotension)Timepoint: delirium incidence twice daily (8am and 8pm) from day 0 to day 14 or discharge ,length of stay, duration of delirium , adverse events till icu discharge . | — |
Countries
India
Contacts
Public ContactDr Ranjay Mahaseth
All India Institute of Medical Sciences Jodhpur
Outcome results
None listed