UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036594 |
|---|---|
| Receipt number | R000041690 |
| Scientific Title | Perioperative response of arginine vasopressin and aquaporin-2 in cardiac surgery |
| Date of disclosure of the study information | 2019/04/24 |
| Last modified on | 2020/02/10 16:04:08 |
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Basic information
Public title
Perioperative response of arginine vasopressin and aquaporin-2 in cardiac surgery
Acronym
Perioperative AVP and AQP2 study
Scientific Title
Perioperative response of arginine vasopressin and aquaporin-2 in cardiac surgery
Scientific Title:Acronym
Perioperative AVP and AQP2 study
Region
| Japan |
Condition
Condition
heart disease required cardiac surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
hypothesis, U-AQP2 levels are increased during perioperative periods in cardiac surgical patients.
Basic objectives2
Others
Basic objectives -Others
To measure U-AQP2 and P-AVP levels during perioperative periods in cardiac surgical patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in P-AVP and U-AQP2
Key secondary outcomes
regression of AVP and AQP2, regression of BNP
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
cardiac surgical patients
Key exclusion criteria
emergency cases or critical cases required management in ICU before surgery, hemodialysis cases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon medical School Chiba Hokusoh Hospital
Division name
Cardiovascular surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
mfujii-cvs@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon medical School Chiba Hokusoh Hospital
Division name
Cardiovascular surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
Homepage URL
mfujii-cvs@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon medical School Chiba Hokusoh Hospital
Address
1715 Kamagari, Inzai, Chiba
Tel
0476-99-1111
n-yamauchi@nms.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
| 2019 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
http://link.springer.com/article/10.1007/s00380-019-01533-8
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s00380-019-01533-8
Number of participants that the trial has enrolled
8
Results
Median plasma arginine vasopressin levels significantly increased to 1.5,15.3*,2.2,1.7(pg/mL) preoperatively, on postoperative days 1, 4, and 7, respectively (*: p=0.0001). Similarly, levels of urine aquaporin-2 markedly increased in 3.4, 25.8**, 9.3, 5.4(ng/mL), respectively (**p=0.0004).
Results date posted
| 2020 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
plasma arginine vasopressin, urine aquaporin-2
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 11 | Month | 07 | Day |
Other
Other related information
blood and urine samples, medical records during this study period
Management information
Registered date
| 2019 | Year | 04 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041690
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
