UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018402 |
|---|---|
| Receipt number | R000021305 |
| Scientific Title | Intravenous amiodarone for the prevention of the postoperative atrial fibrillation after cardiac surgery |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2019/04/18 13:51:35 |
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Basic information
Public title
Intravenous amiodarone for the prevention of the postoperative atrial fibrillation after cardiac surgery
Acronym
amio-af prevention
Scientific Title
Intravenous amiodarone for the prevention of the postoperative atrial fibrillation after cardiac surgery
Scientific Title:Acronym
amio-af prevention
Region
| Japan |
Condition
Condition
elective cardiac surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
intravenous amiodarone is administered for the prevention of postoperative atrial fibrillation when the patient arrives at intensive care unit and it is evaluated the effect.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the incidence of the postoperative atrial fibrillation during 7days after cardiac surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous amiodarone 750mg per day is administered for 3 days after cardiac surgery.
Interventions/Control_2
no intravenous amiodarone
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
combined valve surgery,aortic valve surgery for 70 years of age or more, off pump coronary artery bypass for 65 years of age or more.
Key exclusion criteria
past history of atrial fibrillation
liver dysfunction
shock vital
allergy for amiodarone
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Aoki |
Organization
Showa university
Division name
department of cardiovascular surgery
Zip code
Address
Tokyo Shinagawaku Hatanodai1-5-8
TEL
03-3784-8588
kawaura0919@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Omoto Tadashi |
Organization
Showa university
Division name
Cardiovascular surgery
Zip code
Address
Tokyo Shinagawaku Hatanodai1-5-8
TEL
03-3784-8588
Homepage URL
thoracsurg@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university hospital
Institute
Department
Personal name
Funding Source
Organization
Showa university, department of cardiovascular surgery
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 | 08 | Month | 01 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021305
