Preventive effect of ramelteon on delirium in IC

Phase 3

Recruiting

• Conditions: Patients who need ICU management.; intensive care; D007362

• Registration Number: JPRN-jRCTs041200112
• Lead Sponsor: umaguchi Atushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of ICU-delirium

Secondary Outcome Measures

Name	Time	Method
ength 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.