Patients who need ICU management. intensive care
Conditions
Interventions
Arm ramelteon: Over-encapsulated ramelteon (8 mg) given either orally or via nasogastric tube at 20:00 hours for 14 consecutive nights or until ICU discharge, whichever occurs first.
Arm placebo: Over
Ramelteon
Sponsors
Numaguchi Atushi
Japanese association for acute medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) ICU patients 18 years old or more, expected to stay in ICU for over 48 hours. 2) Patients registered within 48hours of ICU admission and administrated first medication on the registration day.
Exclusion criteria
Exclusion criteria: 1) Patients under 18 years old. 2) Allergy to ramelteon. 3) Patients with severe liver injury (T-Bil >= 10 mg/dL, or ALT >= 750 IU/L). 4) Patients receiving fluvoxamine maleate. 5) Patients already receiving ramelteon therapy before admission. 6) Patients expected to leave ICU within 48 hours of admission. 7) Patients expected to die within 48 hours of admission or be excluded from active treatment. 8) Pregnant or lactating women. 9) Patients expected to be difficult to evaluate delirium by CAM-ICU due to neurological problems such as post-cardiac arreest, head trauma, stroke, or other illness. 10) Absence of written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of ICU-delirium | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of delirium, severity and need for treatment of delirium, length and quality of sleep, length of ICU and hospital stay, 28- and in-hospital mortality, ventilator free days (number of days without ventilator use from day 1 to day 28), dose of sedative drugs. | — |
Contacts
Public ContactAtushi Numaguchi
Nagoya University Hospital
Outcome results
None listed