UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery
Title of the study (Brief title)	The effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after cardiac surgery
Region	Japan

Condition
Condition	patients who receive off-pump coronary artery bypass surgery
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to determine the effect of Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist,after bypass surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of Body Weight
Key secondary outcomes	arrhythmia, pleural effusion, fluid volume from drainage tube, postoperative hospital stay, volume of urine, proportion of electrolyte in blood and urine, BUN, creatinine, eGFP, blood pressure, heart rate, adverse event related to cardiac or vascular system

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tolvapta is administrated in "Tolvaptan" group, instead of regular diuretic medication
Interventions/Control_2	regular diuretic treatment will be administrated
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	The patients who received elective OPCAB surgery
Key exclusion criteria	history of dialysis severe renal failure (eGFR<15mL/min/1.73m2) emergent surgery maximum blood pressure is less than 100mmHg any other patient who are in contraindicated of Torvaptan
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Matsushita
Organization	Juntendo University Faculty of Medicine
Division name	Department of Cardiovascular Surgery
Address	2-1-1, Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Email	saty-m@juntendo.ac.jp

Public contact
Name of contact person	Satoshi Matsushita
Organization	Juntendo University Faculty of Medicine
Division name	Department of Cardiovascular Surgery
Address	2-1-1, Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	saty-m@juntendo.ac.jp

Sponsor
Institute	Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization	Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	順天堂大学医学部

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 25 Day
Last modified on	2017 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012924