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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009957
Receipt No. R000011659
Scientific Title A study on the safety and effectiveness of tolvaptan for patients with fluid retention after valvular surgery
Date of disclosure of the study information 2013/02/05
Last modified on 2015/09/29

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Basic information
Public title A study on the safety and effectiveness of tolvaptan for patients with fluid retention after valvular surgery
Acronym Study of tolvaptan for fluid retention after valve surgery
Scientific Title A study on the safety and effectiveness of tolvaptan for patients with fluid retention after valvular surgery
Scientific Title:Acronym Study of tolvaptan for fluid retention after valve surgery
Region
Japan

Condition
Condition Patients received cardiac surgery for cardiac valvular disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient after valve surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase IV

Assessment
Primary outcomes The days before returning to the preoperative weight
Key secondary outcomes 1.A cumulative urine volume for 48 hours
2.Echocardiography on the seven days
3.Change of Congestive Signs and correction of potassium
4.Change of serum marker (Cr, BUN, Na, K)
5.Usage of diuretics
6.Postoperative length of stay
7.Onset of cardiovascular event
8.Onset of serious adverse event

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 1.Patient who plans a valve surgery (AV, MV, TV, PV)
2.Patients who takes existing diuretic
3.The patient is willing to participate in the study
Key exclusion criteria 1.Patients with hypersensitivity to study drug
2.Anuric patients
3.Patients with hypernatremia
4.Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
5.Malignant tumor
6.Patients with serious hepatic disorder or Serious Renal failure
7.Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Nishi
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 2-2, Yamada-Oka, Suita, Osaka, Japan
TEL 06-6879-3154
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Nishi
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 2-2, Yamada-Oka, Suita, Osaka, Japan
TEL 06-6879-3154
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 05 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 Completed
Date of protocol fixation
2012 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information age, gender, height, weight, underlying disease, complications, previous illness, operative procedure and region of VD, operation other than VD, urine volume, blood pressure, heart rate, congestive signs, correction of potassium, laboratory values(Na, K, Cr, BUN, Hb, T-bil, BNP), echocardiography(LVEF, IVC, LVDd), NYHA classification, medication status, onset of cardiovascular events and serious adverse events

Management information
Registered date
2013 Year 02 Month 05 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011659

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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