UMIN-CTR Clinical Trial

Basic information
Public title	The effect of low dose tolvaptan after cardiovascular surgery
Acronym	The effect of low dose tolvaptan after cardiovascular surgery
Scientific Title	The effect of low dose tolvaptan after cardiovascular surgery
Scientific Title:Acronym	The effect of low dose tolvaptan after cardiovascular surgery
Region	Japan

Condition
Condition	after cardiovascular surgery associated with cardiopulmonary bypass
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	early return to preoperative weight by using tolvaptan after open heart surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Whether returning to the target weight by the 6th postoperative day
Key secondary outcomes	worsening renal function, urine volume / body weight

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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Azosemide 30 mg / day was administered from the 2nd postoperative day. Administer furosemide 10 to 40 mg as appropriate. Within 4 days to return to preoperative weight.
Interventions/Control_2	Azosemide 30 mg/day and tolvaptan 3.75 mg/day was administered from the 2nd postoperative day. Administer furosemide 10 to 40 mg as appropriate. Within 4 days to return to preoperative weight.
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	patients after open heart surgery with cardiopulmonary bypass
Key exclusion criteria	Urgency or emergency operation CKD (dialysis, eGFR<30) Heart failure with EF<40% Heart failure or infection within preoperative 4 weeks Thoracoabdominal aortic replacement surgery and OPCAB Artificial respiration management over 24 hours and reintroduction Tolvaptan allergy Without feeling dry mouth or water ingestion Hypernatremia Patients with pregnant, possibility of pregnancy and pregnancy wish Using tolvaptan preoperatively
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Tadaaki Middle name Last name Koyama
Organization	Kobe City Medical Center General Hospital
Division name	Cardiovascular Surgery
Zip code	650-0047
Address	2-1-1 Minatojimaminamimachi Chuouku Kobe City Hyogo Japan
TEL	078-302-4321
Email	koyamat@kcho.jp

Public contact
Name of contact person	1st name Tadaaki Middle name Last name Koyama
Organization	Kobe City Medical Center General Hospital
Division name	Cardiovascular Surgery
Zip code	650-0047
Address	2-1-1 Minatojimaminamimachi Chuouku Kobe City Hyogo Japan
TEL	078-302-4321
Homepage URL
Email	koyamat@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital
Address	2-1-1 Minatojimaminamimachi Chuouku Kobe City Hyogo Japan
Tel	078-302-4321
Email	rinken@kcho.jp

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	2018 Year 09 Month 03 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	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 24 Day
Date of IRB	2018 Year 08 Month 25 Day
Anticipated trial start date	2018 Year 09 Month 03 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 02 Day
Last modified on	2020 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038761

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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