UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012392 |
|---|---|
| Receipt number | R000014479 |
| Scientific Title | Evaluation of Torvaptan on postoperative edema after cardiac surgery. |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2013/11/24 11:33:45 |
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Basic information
Public title
Evaluation of Torvaptan on postoperative edema after cardiac surgery.
Acronym
Effects of Torvaptan on cardiac surgery
Scientific Title
Evaluation of Torvaptan on postoperative edema after cardiac surgery.
Scientific Title:Acronym
Effects of Torvaptan on cardiac surgery
Region
| Japan |
Condition
Condition
ischemic heart disease, heart valvular disease, diseases of thoracic aorta
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Torvaotan on fluid retension after cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration(Days) to recover preoperative body weight
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients with fluid retension
(2)Patients who did not have enough effects by other diuretics
(3)Patients undergoing cardiac surgery for valvular disease, ischemic heart disease and thoracic aortic aneurysm
(4)Patients who gave written informed consent before treatment
Key exclusion criteria
(1)Patients who had had allergic response to Truvaptan or analogous compound(eg.mozavaptan)
(2) Anuric patients
(3)Patients who do not feel thirst or oral fluid intake difficulty
(4)Hypernatremia(Na>147mEq/L)
(5)Women who are pregnant, breast-feeding or having will of pregnancy
(6)Oral feeding difficulty after surgery
(7)Malignacy
(8)Severe hepatic damage or renal dysfunction
(9)Others judged as innapropriate candidate by the researcher(s)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kondo |
Organization
Hirosaki University
Division name
Thoracic and Cardiovascular Surgery
Zip code
Address
5 Zaifu-cho, Hirosaki, Japan
TEL
0172-39-5074
kondo18@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Kondo |
Organization
Hirosaki University
Division name
Thoracic and Cardiovascular Surgery
Zip code
Address
5 Zaifu-cho, Hirosaki, Japan
TEL
0172-39-5074
Homepage URL
kondo18@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Thoracic and Cardiovascular Surgery, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic and Cardiovascular Surgery, Hirosaki University Graduate School of Medicine
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
| 2014 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
random sampling, prospective analysis
Management information
Registered date
| 2013 | Year | 11 | Month | 24 | Day |
Last modified on
| 2013 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014479
