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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036594
Receipt No. 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

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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
Email 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
Email mfujii-cvs@umin.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041690

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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