UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016541 |
|---|---|
| Receipt number | R000019200 |
| Scientific Title | The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial) |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2021/04/15 00:58:10 |
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Basic information
Public title
The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial)
Acronym
MELIt Trial
Scientific Title
The efficacy of ramelteon, selective melatonin receptor agonist, during the critical care: MELIt Trial (Melatonin Evaluation of Lowered Inflammation in ICU Trial)
Scientific Title:Acronym
MELIt Trial
Region
| Japan |
Condition
Condition
Patients who are at least 20 years, and are admitted to an emergency and medical ICU in our hospital.
Classification by specialty
| Medicine in general | Surgery in general | Anesthesiology |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We study to clarify the efficacy of ramelteon, which has effect for anti-imflamention and prevention of the delirium, for ICU patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The primary outcome is the duration in our emergency and medical ICU admission.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We give ramelteon to our emergency and medical ICU patients.
Interventions/Control_2
We give placebo to our emergency and medical ICU patients.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are at least 20 years, and are admitted to an emergency and medical ICU in our hospital.
Key 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.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Numaguchi |
Organization
Nagoya university hospital.
Division name
The emergency and critical care department.
Zip code
Address
Tsurumai-cho 65, syowa-ku, Nagoya, Aichi, Japan.
TEL
+81-52-744-2659
nummer0116@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Nishikimi |
Organization
Nagoya university hospital.
Division name
The emergency and critical care department.
Zip code
Address
Tsurumai-cho 65, syowa-ku, Nagoya, Aichi, Japan.
TEL
+81-52-744-2659
Homepage URL
m0528332626@yahoo.co.jp
Sponsor or person
Institute
The emergency and critical care department, Nagoya university hospital.
Institute
Department
Personal name
Funding Source
Organization
Nagoya university hospital.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29595562/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29595562/
Number of participants that the trial has enrolled
88
Results
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).
Results date posted
| 2021 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were ICU patients who could take medicines orally or through a nasogastric tube during the first 48 hours of admission.
Participant flow
A total of 88 subjects were randomized to the ramelteon group (45 subjects) or the placebo group (43 subjects).
Adverse events
None
Outcome measures
the duration of ICU stay
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019200
