UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011172
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email m1111321@med.osaka-cu.ac.jp

Sponsor
Institute Osaka city 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.