UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013153 |
|---|---|
| Receipt number | R000015334 |
| Scientific Title | Usefulness of Tolvaptan preventing for excessive body fluid retension after cardiac surgery |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2018/08/18 10:46:23 |
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Basic information
Public title
Usefulness of Tolvaptan preventing for excessive body fluid retension after cardiac surgery
Acronym
Usefulness of Tolvaptan preventing for excessive body fluid retension after cardiac surgery
Scientific Title
Usefulness of Tolvaptan preventing for excessive body fluid retension after cardiac surgery
Scientific Title:Acronym
Usefulness of Tolvaptan preventing for excessive body fluid retension after cardiac surgery
Region
| Japan |
Condition
Condition
valvular heart disease, ischemic heart disease, aortic aneurysm, aortic dissection, cardiac tumor
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of Tolvaptan preventing for excessive body fluid retention and renal function after cardiac surgery using artificial cardiopulmonary device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
volume of urine , change of body weight, abnormality of the electrolyte
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
oral furosemide at a dose of 10-20mg and oral tolvaptan at a dose of 7.5mg daily
Interventions/Control_2
oral furosemide at a dose of 10-20mg daily
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)patients perfomed cardiac surgery using artificial cardiopulmonary device
2)patients received explanation enough and obtained its consent in a sentence
Key exclusion criteria
1)patients have hypersensitivity to this agent or similar medicine
2)anuria
3)hypernatremia
4)pregnant patients
5)malignant tumor
6)severe hepatopathic patients
7)dialysis patients
8)If the attending physician determines that the patient is an inadequate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sawaka Tanabe |
Organization
University of Fukui
Division name
Cardiovascular Surgery
Zip code
Address
Shimoaitsuki 23-3,Matsuoka,Eiheiji-cho,Yoshida-gun,Fukui-ken
TEL
0776-61-3111
tanabes@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sawaka Tanabe |
Organization
University of Fukui
Division name
Department of Cardiovascular Surgery
Zip code
Address
Shimoaitsuki 23-3,Matsuoka,Eiheiji-cho,Yoshida-gun,Fukui-ken
TEL
0776-61-3111
Homepage URL
tanabes@u-fukui.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Faculty of Medical Sciences,University of Fukui
Institute
Department
Personal name
Funding Source
Organization
None
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
福井大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015334
