UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025594 |
|---|---|
| Receipt number | R000029455 |
| Scientific Title | Effect of tolvaptan in the early post operative period after cardiac surgery |
| Date of disclosure of the study information | 2017/01/11 |
| Last modified on | 2018/05/09 09:52:11 |
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Basic information
Public title
Effect of tolvaptan in the early post operative period after cardiac surgery
Acronym
Effect of tolvaptan after cardiac surgery
Scientific Title
Effect of tolvaptan in the early post operative period after cardiac surgery
Scientific Title:Acronym
Effect of tolvaptan after cardiac surgery
Region
| Japan |
Condition
Condition
Patients undergoing cardiac surgery using cardiopulmonary bypass
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effect of tolvaptan for early postoperative period after cardiac surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required to restore preoperative body weight
Key secondary outcomes
Unine output
Total amount of furosemide given
Incidence of worsening renal function (WRF)
Incidence of postoperative atrial fibrillation (new onset)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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 administration of tolvaptan starting postoperative day 1.
Tolvaptan is given until the body weight restores preoperative level or maximum 5 days.
Interventions/Control_2
Conventional postoperative fluid management using oral and/or intravenous furosemide
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
Adult patients who underwent cardiac surgery using cardiopulmonary bypass
Key exclusion criteria
Renal insufficiency (Serum creatinine level > 3.0 mg/dl or on chronic dialysis)
Serum Na level > 147 mEq/L on postoperative day 1
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motonobu Nishimura |
Organization
Tottori University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6577
nishimur@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motonobu Nishimura |
Organization
Tottori University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6577
Homepage URL
nishimur@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Surgery
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Surgery
Tottori University Hospital
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
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1253/circj.CJ-17-0967
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 | 07 | 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
| 2018 | Year | 05 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2018 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029455
