UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009957 |
|---|---|
| Receipt number | 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 23:09:43 |
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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
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
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011659
