UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011172 |
|---|---|
| Receipt number | R000013087 |
| Scientific Title | A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery |
| Date of disclosure of the study information | 2013/07/12 |
| Last modified on | 2017/08/13 17:32:44 |
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Basic information
Public title
A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery
Acronym
A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery
Scientific Title
A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery
Scientific Title:Acronym
A study on the safety and efficasy of tolvaptan for patients with fluid retention after cardiothoracic surgery
Region
| Japan |
Condition
Condition
Patients received cardiothoracic surgery with congestive heart failure.
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We research the early improvement of fluid retention and renal function through the administration of tolvaptan for the patient after cardiothoracic surgery with congestive heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
1 The days before returning to the preoperative weight
2 Nomarization ratio of the serum creatinine after cardiothoracic surgery
Key secondary outcomes
1. Body weight, cumulative urine volume, and volume of drinking water.
2. Incidence of the arrhythmia.
3. Congestive signs.
4. Thoracic X-ray, echocardiography.
5. Serum Na, K, osmolality, rennin activity.
6. Urinary Na, K, osmolality,
7. Usage of diuretics in hospitalization period.
8. The number of Re-hospitalization times and total days in hospitalization period after surgery.
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional therapy group
Interventions/Control_2
Tolvaptan low dose group
Interventions/Control_3
Tolvaptan standard dose group
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 Patient show body weight increase 1.5kg or more compared with preoperative weight in 2POD, with fluid retention after cardiothoracic surgery..
2 In hospitalized patients.
3 The patient is willing to participate in the study.
Key exclusion criteria
1 Patients with cardiogenic shock.
2 Patients with cardiac assist device.
3 Patients with disease, complication, and symptom, as follows.
1.Dehydration, 2.Adipsia, 3.Hypertrophic cardiomyopathy, 4.Hepatic coma, 5.Uncontrolled diabetes mellitus, 6.Anuria, 7.Disability of urinary excretion.
4 Amyloid myocarditis.
5 Patients with systolic blood pressure <90mmHg.
6 Patients with serum Na > 147 mEq/L or serum K > 5.5 mEq/L or T - bilirubin > 3.0 mg/dL.
7 Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigefumi Suehiro |
Organization
Osaka city university graduate school of medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-4-3, Asahimachi Abenoku, Osaka, Japan
TEL
06-6645-3841
shigefumis@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Suehiro |
Organization
Osaka City General Hospital
Division name
Cardiovascular Surgery
Zip code
Address
2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL
06-6929-1221
Homepage URL
m1111321@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city 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 | 07 | Month | 12 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013087
