UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011039 |
|---|---|
| Receipt number | R000012924 |
| Scientific Title | The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2017/06/28 16:11:14 |
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Basic information
Public title
The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery
Acronym
The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery
Scientific Title
The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery
Scientific Title:Acronym
The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery
Region
| Japan |
Condition
Condition
patients who receive off-pump coronary artery bypass surgery
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine the effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after bypass surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Body Weight
Key secondary outcomes
arrhythmia, pleural effusion, fluid volume from drainage tube, postoperative hospital stay, volume of urine, proportion of electrolyte in blood and urine, BUN, creatinine, eGFP, blood pressure, heart rate, adverse event related to cardiac or vascular system
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvapta is administrated in "Tolvaptan" group, instead of regular diuretic medication
Interventions/Control_2
regular diuretic treatment will be administrated
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
The patients who received elective OPCAB surgery
Key exclusion criteria
history of dialysis
severe renal failure (eGFR<15mL/min/1.73m2)
emergent surgery
maximum blood pressure is less than 100mmHg
any other patient who are in contraindicated of Torvaptan
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsushita |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-1-1, Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
saty-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsushita |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-1-1, Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
Homepage URL
saty-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
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
順天堂大学医学部
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012924
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
