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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013153
Receipt No. 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

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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
Email 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
Email tanabes@u-fukui.ac.jp

Sponsor
Institute Department of Cardiovascular Surgery, Faculty of Medical Sciences,University of Fukui
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015334

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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