UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031762 |
|---|---|
| Receipt number | 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 10:27:21 |
* 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
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
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
suzuki.keito@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036262
