UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006812 |
|---|---|
| Receipt number | R000007354 |
| Scientific Title | The Japan study of treatment for acute kidney injury in post-cardiovascular surgery patients by atrial natriuretic peptide |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2017/03/29 12:57:29 |
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Basic information
Public title
The Japan study of treatment for acute kidney injury in post-cardiovascular surgery patients by atrial natriuretic peptide
Acronym
JAPAN
Scientific Title
The Japan study of treatment for acute kidney injury in post-cardiovascular surgery patients by atrial natriuretic peptide
Scientific Title:Acronym
JAPAN
Region
| Japan |
Condition
Condition
Cardiovascular surgery-associated acute kidney injury
Classification by specialty
| Nephrology | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the renal effects of atrial natriuretic peptide for protecting and treating acute kideny injury in cardiovascular surgery patients by a multicenter, randomized controlled trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Renal function, rate and duration of renal replacement therapy 3 months after administration of atrial natriuretic peptide
Key secondary outcomes
Days of ICU stay and hospital stay and medical costs 3 months after administration of atrial natriuretic peptide
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carperitide (atrial natriuretic peptide)
Interventions/Control_2
5% glucose
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
Randamization of the cardiovascular surgery patients associated with acute kidney injury
Key exclusion criteria
1) hypotension
2) right ventricular myocardial infarction
3) dehydration
4) patients with chronic kidney disease on hemodialysis
5) patients on percutaneous cardio-pulmonary support (PCPS)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chieko Mitaka |
Organization
Tokyo Medical and Dental University
University Graduate School
Division name
Critical Care Medicine
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5653
c.mitaka.icu@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chieko Mitaka |
Organization
Tokyo Medical and Dental University Hospital of Medicine
Division name
Intensive Care Unit
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5653
Homepage URL
c.mitaka.icu@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Hospital of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University Graduate School, Departmnet of Critical Care Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京医科歯科大学医学部付属病院、群馬大学医学部付属病院、筑波大学附属病院、信州大学医学部付属病院、慶應義塾大学病院、横浜市立みなと赤十字病院、名古屋大学医学部付属病院、大阪大学医学部付属病院、香川大学医学部付属病院、愛媛大学医学部付属病院、鹿児島大学病院、自治医科大学附属さいたま医療センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of the 77 randomized patients, 37 were in the ANP group and 40 were in the placebo group. Although ANP significantly (p=0.018) increased urine output, it did not significantly improve renal function compared with placebo. There were no significant differences between the groups in the renal replacement therapy rate, the length of the intensive care unit and hospital stays, or medical cost. Atrial natriuretic peptide infusion did not show a renoprotective effect or cost-saving effect in the treatment of cardiac surgery-associated acute kidney injury.
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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 01 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007354
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