UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010970 |
|---|---|
| Receipt number | 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 | 2024/06/24 12:20:56 |
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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
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
mkoi@med-kagawa-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Faculty of medicine,Kagawa university
Institute
Department
Personal name
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
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
| 2026 | 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
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012838
