UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027311 |
|---|---|
| Receipt number | R000029491 |
| Scientific Title | A Multicenter Randomized Controlled Trial: The Efficacy of Suvorexant in Prevention of Postoperative Delirium after Cardiac Surgery |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2020/01/27 19:13:34 |
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Basic information
Public title
A Multicenter Randomized Controlled Trial: The Efficacy of Suvorexant in Prevention of Postoperative Delirium after Cardiac Surgery
Acronym
A Multicenter Randomized Controlled Trial: The Efficacy of Suvorexant in Prevention of Postoperative Delirium after Cardiac Surgery
Scientific Title
A Multicenter Randomized Controlled Trial: The Efficacy of Suvorexant in Prevention of Postoperative Delirium after Cardiac Surgery
Scientific Title:Acronym
A Multicenter Randomized Controlled Trial: The Efficacy of Suvorexant in Prevention of Postoperative Delirium after Cardiac Surgery
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether suvorexant decreases the incidence of delirium after cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of delirium determined by CAM-ICU (for a maximum of 7 days) after cardiac surgery in ICU
Key secondary outcomes
1. Proportion of the number of times that a patient is deemed CAM-ICU positive to the total number of CAM-ICU assessment during ICU stay
2. Length of mechanical ventilation
3. Length of ICU stay
4. Length of hospital stay
5. Development of hyperactive delirium requiring psychiatric consultation or antipsychotic medication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
suvorexant 15 mg/day during ICU stay (for a maximum of 7 days)
Interventions/Control_2
placebo during ICU stay (for a maximum of 7 days)
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients meeting the following requirements
･ undergoing elective cardiac surgery using cardiopulmonary bypass and without circulatory arrest or selective cerebral perfusion
･ admitted to ICU after surgery
･ at high risk for / with symptoms of insomnia
･ first-person consent to participation
Key exclusion criteria
Patients meeting any of the following criteria
･ taking suvorexant at the time of enrollment
･ taking ramelteon at the time of enrollment
･ history of hypersensitivity to suvorexant
･ taking a drug that is incompatible with suvorexant
･ intracranial organic lesion
･ diagnosed as dementia or scored 21 or less
on Mini-Mental State Examination
･ depression
･ taking anti-psychotic drugs
･ alcohol abuse
･ severe renal dysfunction that requires maintenance dialysis (preoperatively)
･ severe hepatic dysfunction (Child-Pugh class B or C)
･ restriction in the evaluation of delirium using CAM-ICU in terms of impairment in communication (in Japanese) and/or physical disability
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kariya |
Organization
Yokohama City University Medical Center
Division name
Intensive Care Department
Zip code
2320024
Address
4-57 Urafune-cho, Minami-ku Yokohama, Kanagawa, 232-0024, Japan
TEL
+81-45-261-5656
tkariya@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kariya |
Organization
Yokohama City University Medical Center
Division name
Intensive Care Department
Zip code
2320024
Address
4-57 Urafune-cho, Minami-ku Yokohama, Kanagawa, 232-0024, Japan
TEL
+81-45-261-5656
Homepage URL
tkariya@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (Grant-in-Aid for Scientific Research C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7627
rinri@yokohama-cu.ac.jp
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
| 2017 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029491
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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