The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial)
Phase 3
- Conditions
- Patients who are at least 20 years, and are admitted to an emergency and medical ICU in our hospital.
- Registration Number
- JPRN-UMIN000016541
- Lead Sponsor
- The emergency and critical care department, Nagoya university hospital.
- Brief Summary
As the primary endpoint, there was a trend toward decrease in the duration of ICU stay (4.56 d) in the ramelteon group compared with the placebo group (5.86 d) (p = 0.082 and p = 0.028 before and after adjustments).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria is the patient who is contraindicated for ramelteon, who is not receiving ramelteon therapy, who is admitted to our ICU during at least 2 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the duration in our emergency and medical ICU admission.
- Secondary Outcome Measures
Name Time Method Key secondary outcomes are 1. the transition of inflammation markers, 2. the incidence, severity of delirium, 3. the mortality rate when they are discharged from our emergency and medical ICU.