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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033992
Receipt No. R000038761
Scientific Title The effect of low dose tolvaptan after cardiovascular surgery
Date of disclosure of the study information 2018/09/03
Last modified on 2018/09/02

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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
Middle name
Last name Tadaaki Koyama
Organization Kobe City Medical Center General Hospital
Division name Cardiovascular Surgery
Zip code
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
Middle name
Last name Tadaaki Koyama
Organization Kobe City Medical Center General Hospital
Division name Cardiovascular Surgery
Zip code
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
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
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
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
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
2018 Year 09 Month 02 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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