UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004433 |
|---|---|
| Receipt number | R000005299 |
| Scientific Title | Multi-center randomized study of prophylactic effect of Landiorol for prevention of atrial fibrillation after cardiac surgery. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2010/10/21 22:15:00 |
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Basic information
Public title
Multi-center randomized study of prophylactic effect of Landiorol for prevention of atrial fibrillation after cardiac surgery.
Acronym
Prophylactic effect of Landiorol for prevention of atrial fibrillation after cardiac surgery.
Scientific Title
Multi-center randomized study of prophylactic effect of Landiorol for prevention of atrial fibrillation after cardiac surgery.
Scientific Title:Acronym
Prophylactic effect of Landiorol for prevention of atrial fibrillation after cardiac surgery.
Region
| Japan |
Condition
Condition
Atrial fibrillation after cardiac surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prophylactic effect of Landiorol for prevention of atrial fibrillation after cardiac surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of atrial fibrillation after cardiac surgery
Key secondary outcomes
Degree and frequency of adverse events(death, stroke, MI, LOS, severe bradycardia, severe hypotension or decrease of CI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Continuous infusion of Landiorol at a rate of 2 microgram/kg/min from POD1 to POD3
Interventions/Control_2
Untreated
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
All adult patients undergoing cardiac surgery
Key exclusion criteria
Cardiogenic shock, chronic atrial fibrillation, bronchial asthma, pulmonary hypertension, untreated pheochromocytoma, severe bradycardia including A-V block more than II degree, severe allergy to Landiorol, a judgement of attending physician that patient participation would be inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuji Kunitomo |
Organization
Kumamoto University
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Takaji |
Organization
Kumamoto University
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
Homepage URL
Sponsor or person
Institute
Graduate school of medical sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 21 | Day |
Last modified on
| 2010 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005299
