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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010970
Receipt No. R000012838
Scientific Title Elucidation of renal function protection with human atrial natriuretic peptide (hANP)
Date of disclosure of the study information 2013/06/14
Last modified on 2020/01/01

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Basic information
Public title Elucidation of renal function protection with human atrial natriuretic peptide (hANP)
Acronym Elucidation of renal function protection with hANP
Scientific Title Elucidation of renal function protection with human atrial natriuretic peptide (hANP)
Scientific Title:Acronym Elucidation of renal function protection with hANP
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The mechanism of renal function protection effect of human atrial natriuretic peptide (hANP) is not clearly. The aim of this study is elucidation for the one of mechanism of renal function protection if the use of hANP can reduce tubular disorder because hANP controls inflammatory cytokine after cardiovascular operation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urine epidermal growth factor and serum Inflammatory cytokine. These are measured before operation until 7th day after operation.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients of selective off pump coronary artery bypass grafting
Key exclusion criteria preoperative renal disfunction , not heart failure
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mari
Middle name
Last name Koizumi
Organization Kagawa university
Division name Department of anesthesia
Zip code 761-0793
Address 1750-1 ikenobe,Miki-cho,Kita-gun,Kagawa
TEL 087-898-5111
Email mkoi@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Mari
Middle name
Last name Koizumi
Organization Faculty of medicine,Kagawa university
Division name Department of anesthesiology
Zip code 761-0793
Address 1750-1 ikenobe,Miki-cho,Kita-gun,Kagawa
TEL 087-898-5111
Homepage URL
Email mkoi@med-kagawa-u.ac.jp

Sponsor
Institute Department of anesthesiology, Faculty of medicine,Kagawa university
Institute
Department

Funding Source
Organization Department of anesthesiology, Faculty of medicine,Kagawa university
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 Clinical research support center,Faculty of medicine,Kagawa university
Address 1750-1 ikenobe,Miki-cho,Kita-gun,Kagawa
Tel 087-898-5111
Email chiken@med.kagawa-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
2013 Year 06 Month 14 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 15 Day
Date of IRB
2009 Year 12 Month 08 Day
Anticipated trial start date
2009 Year 12 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Even if preoperative renal function is normal, temporary tubular disfunction is occurred after OPCAB. We elucidate that tubular disorder is reduced by giving hANP during operation until postoperative day 1.

Management information
Registered date
2013 Year 06 Month 14 Day
Last modified on
2020 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012838

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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