UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016717 |
|---|---|
| Receipt number | R000019382 |
| Scientific Title | Evaluation of the antiarrythmic effect of dexmedetomidine |
| Date of disclosure of the study information | 2015/03/05 |
| Last modified on | 2020/10/28 08:46:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the antiarrythmic effect of dexmedetomidine
Acronym
Evaluation of the antiarrythmic effect of dexmedetomidine
Scientific Title
Evaluation of the antiarrythmic effect of dexmedetomidine
Scientific Title:Acronym
Evaluation of the antiarrythmic effect of dexmedetomidine
Region
| Japan |
Condition
Condition
Adult patients after cardiovascular surgery
Classification by specialty
| Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examinate whether dexmedetomidine sedation reduce the incidence of postoperative atrial fibrillation in cardiovascular surgery patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative atrial fibrillation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Dexmedetomidine
Interventions/Control_2
Saline
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
Adult patients who are admitted to intensive care unit after cardiovascular surgery at Yamagata University Hospital.
Key exclusion criteria
The patients who have chronic atrial fibrillation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ayuka |
| Middle name | |
| Last name | Narisawa |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL
023-628-5400
asakamoto-ygt@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ayuka |
| Middle name | |
| Last name | Narisawa |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL
023-628-5400
Homepage URL
asakamoto-ygt@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Yamagata University Faculty of Medicine
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
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2, Iida-nishi, yamagata-shi, Yamagata JAPAN
Tel
0236285015
ikekenkyu@jm.kj.yamagata-u.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
山形大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 05 | 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
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2015 | Year | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019382
