UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029844 |
|---|---|
| Receipt number | R000033505 |
| Scientific Title | Antiarrhythmic Effects of landiolol in cardiac surgery. Prospective study. |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2017/11/06 18:28:00 |
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Basic information
Public title
Antiarrhythmic Effects of landiolol in cardiac surgery. Prospective study.
Acronym
antiarrhythmic effect of landiolol in cardiac surgery
Scientific Title
Antiarrhythmic Effects of landiolol in cardiac surgery. Prospective study.
Scientific Title:Acronym
antiarrhythmic effect of landiolol in cardiac surgery
Region
| Japan |
Condition
Condition
aortic valve stenosis, aortic valve insufficiency, mitral valve stenosis, mitral valve insufficiency
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate of antiarrhytmic effects of landiol in cardiac surgery.
1st endpoints
#1 postoperative atrial fibrillation (af)
#2 intraoperative ventricular arrhythmia
2nd endpoints
#3 postoperative mortality and morbidity
#4 abnormality of blood chemistry, inflammatory, oxidative stress and ischemic response
#5 hemodynamics during/after surgery
#6 duration of hospitalization and ICU stay
#7 incidence of arrhythmia after CPB(cardiopulmonary bypass)
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative af
Incidence of arrhythmia after CPB
Key secondary outcomes
Complication and mortality after surgery
hemodynamics during/after surgery
duration of hospitalization and ICU stay
abnormality of blood chemistry, inflammatory, oxidative stress and ischemic response
duration of weaning of CPB
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In landiolol treatment group, patients will be given landiolol intravenously during/after CPB. Landiolol will continuously administrate for 48 hours after begining of CPB.
Interventions/Control_2
On the other, in control group, patients will be given normal seline intravenously.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)aortic valve stenosis and/or aortic valve insufficiency
2)severity of aortic valve stenosis and/or aortic valve insufficiency are diagnosed as severe grade by preoperative echocardiography.
3)age limtation: 20 =/<, <85 years
4)all participants should obtain written informed consent of this study
Key exclusion criteria
1) emergency surgery
2) shock status before surgery
3) bradycardia (HR<50 bpm),
4) severe AV block
5)additional surgery (CABG, etc)
5) NYHA4
6) The patient who judged a doctor to be inappropriate as a subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Takahashi |
Organization
University of Tsukuba
Division name
Faculty of medicine, department of Anesthesiology
Zip code
Address
Tennodai1-1-1, Tsukuba, Ibaraki, JAPAN
TEL
029-853-3092
shinjitk@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Takahashi |
Organization
University of Tsukuba
Division name
Faculty of medicine, department of Anesthesiology
Zip code
Address
Tennodai1-1-1, Tsukuba, Ibaraki, JAPAN
TEL
029-853-3092
Homepage URL
shinjitk@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2017 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033505
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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