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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027311
Receipt No. 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 2019/07/09

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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
Email 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
Email tkariya@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Email 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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 11 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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