UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013365 |
|---|---|
| Receipt number | R000015592 |
| Scientific Title | Efficacy of tolvaptan in transurethral resection of prostate: A prospective randomized study |
| Date of disclosure of the study information | 2014/05/11 |
| Last modified on | 2017/05/08 12:58:24 |
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Basic information
Public title
Efficacy of tolvaptan in transurethral resection of prostate: A prospective randomized study
Acronym
Efficacy of tolvaptan in transurethral resection of prostate
Scientific Title
Efficacy of tolvaptan in transurethral resection of prostate: A prospective randomized study
Scientific Title:Acronym
Efficacy of tolvaptan in transurethral resection of prostate
Region
| Japan |
Condition
Condition
Benign prostatic hypertrophy
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine the efficacy of tolvaptan in transurethra resection of prostate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change of serum potassium levels and occurrence of TUR syndrome
Key secondary outcomes
1) perioperative mortality
2) neurological and circuratory abnormality
3) serum creatinine levels
4) lactate levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
intake of tolvaptan 7.5mg as a preoperative medication
Interventions/Control_2
intake of tolvaptan 7.5mg as a preoperative medication
Interventions/Control_3
no intake of tolvaptan as conventional treatment
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
Key inclusion criteria
1) Benign prostatic hypertrophy
2) male: 20-89 year-old
3) patients showed consent of this study
Key exclusion criteria
1) emergency operation
2) simultaneously having different operation
3) serum potassium level <125mmol/l
4) having severe coronary diseases and cerebral vessel diseases
5) having severe liver dysfunctions
6) hyperkalemia
7) hemodialysis
8) permanent pacemaker
9) medication of CYP3A4 inhibitors
10) medication of vasopression related drugs
11) medication of inotropic agents
12) medication of Potassium-sparing diuretics
13) BMI>or=35
14) Coagulation disorder
15) Severe complication with a diagnosis of 6 months remaining
16) Participation in other intervention studies
17) being judged as not appropriate for this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
ane022@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Nakahira |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
72-683-1221
Homepage URL
ane052@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00168
Org. issuing International ID_1
JMACCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪医科大学および大阪医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 07 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015592
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