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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031762
Receipt No. R000036262
Scientific Title Study of body fluid management in patients after cardiac surgery by preoperative administration of tolvaptan
Date of disclosure of the study information 2018/04/01
Last modified on 2020/06/01

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Basic information
Public title Study of body fluid management in patients after cardiac surgery by preoperative administration of tolvaptan
Acronym Study of body fluid management by preoperative administration of tolvaptan
Scientific Title Study of body fluid management in patients after cardiac surgery by preoperative administration of tolvaptan
Scientific Title:Acronym Study of body fluid management by preoperative administration of tolvaptan
Region
Japan

Condition
Condition Cardiac disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preoperative administration of tolvaptan facilitates postoperative fluid control.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of days until the peoperative body weight plus minus 1kg
Key secondary outcomes AVP, renin, aldosterone, BUN, Cre, eGFR, Na, K, Alb, osmotic pressure
postoperative weight / urine volume, number of hospital days, time to withdrawal of the ventilator, number of thoracic punctures, postoperative atrial fibrillation, infection, death

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of tolvaptan
Interventions/Control_2
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 1.Person undergoing cardiac surgery
2.Those who have consent
Key exclusion criteria 1.Allergy of this drug
2.serious liver/renal dysfunction
3.Dialysis patients
4.Emergency surgery case
5.Those who have made a request for refusal in participating in this research
6.Others who judged that the research director is inappropriate as the research subject
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Keito
Middle name
Last name Suzuki
Organization Nihon University School of Medicine
Division name Cardiovascular Surgery
Zip code 173-8610
Address 30-1 Oyaguchi-kamimachi Itabashi-ku Tokyo, 173-8610, Japan
TEL 81-3-3972-8111
Email suzuki.keito@nihon-u.ac.jp

Public contact
Name of contact person
1st name keito
Middle name
Last name Suzuki
Organization Nihon University School of Medicine
Division name Cardiovascular Surgery
Zip code 173-8610
Address 30-1 Oyaguchi-kamimachi Itabashi-ku Tokyo, 173-8610, Japan
TEL 81-3-3972-8111
Homepage URL
Email suzuki.keito@nihon-u.ac.jp

Sponsor
Institute Nihon University 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 Itabashi Hospital Clinical Research Ethics Review Committee
Address 30-1 Oyaguchi-kamimachi Itabashi-ku Tokyo, 173-8610, Japan
Tel 81-3-3972-8111
Email takei.masami@nihon-u.ac.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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 04 Month 01 Day
Date of IRB
2018 Year 03 Month 13 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
2019 Year 07 Month 01 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 16 Day
Last modified on
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036262

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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