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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025594
Receipt No. 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

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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
Email 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
Email nishimur@med.tottori-u.ac.jp

Sponsor
Institute Division of Cardiovascular Surgery
Tottori University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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