UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003378 |
|---|---|
| Receipt number | R000004103 |
| Scientific Title | Evaluation of the preventive effect of landiolol on postoperative atrial fibrillation |
| Date of disclosure of the study information | 2010/03/25 |
| Last modified on | 2018/12/05 17:25:52 |
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Basic information
Public title
Evaluation of the preventive effect of landiolol on postoperative atrial
fibrillation
Acronym
PELTA(Preventive effect of landiolol on postoperative atrial fibrillation) study
Scientific Title
Evaluation of the preventive effect of landiolol on postoperative atrial
fibrillation
Scientific Title:Acronym
PELTA(Preventive effect of landiolol on postoperative atrial fibrillation) study
Region
| Japan |
Condition
Condition
Postoperative atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the preventive effect of landiolol to postoperative atrial
fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
*Occurrence of postoperative atrial fibrillation
*Evaluation UCG,inflammatory marker
Key secondary outcomes
*Ventilation time
*ICU days
*Hospital days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration landiolol
(1micro-g/kg/min) depending on assignment
Interventions/Control_2
Administration landiolol
(2micro-g/kg/min) depending on assignment
Interventions/Control_3
Usual care(not administrate landiolol before atrial fibrillation)
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*all elective cases in our department
(cardiac and aortic surgery)
Key exclusion criteria
*existence of severe bronchial asthma
*existence of severe DM
*persistent atrial fibrillation before entering ICU
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University Hospotal
Division name
Cardiovascular Surgery
Zip code
Address
Aobaku seiryocho 1-1,Sendai city, Miyagi prefecture
TEL
022-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University Hospotal
Division name
Cardiovascular Surgery
Zip code
Address
Aobaku seiryocho 1-1,Sendai city, Miyagi prefecture
TEL
022-717-7222
Homepage URL
yoshisaiki@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Sugery,Tohoku University Hospital
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
東北大学病院(宮城県) /Tohoku University Hospital(Miyagi pref.)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 25 | 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
| 2010 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 25 | Day |
Last modified on
| 2018 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004103
