UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037141 |
|---|---|
| Receipt number | R000042312 |
| Scientific Title | Retrospective Cohort Study on post-operative acute kidney injury in non-cardiac surgery |
| Date of disclosure of the study information | 2019/06/24 |
| Last modified on | 2019/06/23 07:28:27 |
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Basic information
Public title
Retrospective Cohort Study on post-operative acute kidney injury in non-cardiac surgery
Acronym
NARA-AKI Cohort Study
Scientific Title
Retrospective Cohort Study on post-operative acute kidney injury in non-cardiac surgery
Scientific Title:Acronym
NARA-AKI Cohort Study
Region
| Japan |
Condition
Condition
Acute kidney injury
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate predictors of post-operative acute kidney injury and predictors of prognosis of post-operative acute kidney injury
Basic objectives2
Others
Basic objectives -Others
To investigate predictors of post-operative acute kidney injury from following variables: pre-operative characteristics (age, sex, comorbidities, use of medications), intra-operative factors (fluid balance, transfusion, use of medication, blood pressure, the amount of bleeding). Also, to investigate predictors of long-term prognosis after post-operative acute kidney injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
post-operative acute kidney injury, long-term outcomes (death, cardiovascular events, infection requiring hospitalization, development of malignancy)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults (age>=18) who underwent non-cardiac surgery under general anesthesia from April 1, 2007 to December 31, 2014.
Key exclusion criteria
Urologic surgery, obstetric surgery, missing creatinine value peri-operatively, pre-operative dialysis
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Tagawa |
Organization
Nara Medical University
Division name
Department of Nephrology
Zip code
6348521
Address
840 Shijo-cho, Kashihara-shi, Nara, 6348521, Japan
TEL
0744298865
tagawam@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Tagawa |
Organization
Nara Medical University
Division name
Department of Nephrology
Zip code
6348521
Address
840 Shijo-cho, Kashihara-shi, Nara, 6348521, Japan
TEL
0744298865
Homepage URL
tagawam@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical Univerisity
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
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara-shi, Nara, 6348521, Japan
Tel
0744-22-3051
f-okumura@naramed-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
| 2019 | Year | 06 | Month | 24 | 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
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study. The data is being collected currently.
Management information
Registered date
| 2019 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042312
