UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030004 |
|---|---|
| Receipt number | R000034264 |
| Scientific Title | Prognosis of acute kidney injury after major abdominal surgery |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2018/08/02 14:16:02 |
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Basic information
Public title
Prognosis of acute kidney injury after major abdominal surgery
Acronym
Acute kidney injury after abdominal surgery
Scientific Title
Prognosis of acute kidney injury after major abdominal surgery
Scientific Title:Acronym
Acute kidney injury after abdominal surgery
Region
| Japan |
Condition
Condition
patients who underwent major abdominal surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to determine perioperative risk factor andprognosis of acute kidney injury after major abdominal surgery
Basic objectives2
Others
Basic objectives -Others
association between postoperative chronic kidney disease and acute kidney injury
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of acute kidney injury and chronic kidney disease
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent major abdominal surgery
Key exclusion criteria
chronic kidney disease
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morita Saori |
Organization
Kawasaki Municipal Tama Hospital
Division name
Anesthesiology
Zip code
Address
1-30-37, Syukugawara, Tama-ku, Kawasaki
TEL
044(933)8111
saori-m@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tateda Takeshi |
Organization
Kawasaki Municipal Tama Hospital
Division name
Anesthesiology
Zip code
Address
1-30-37, Syukugawara, Tama-ku, Kawasaki
TEL
044(933)8111
Homepage URL
t2tateda@marianna-u.ac.jp
Sponsor or person
Institute
Kawasaki Municipal Tama Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
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
川崎市立多摩病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 20 | 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
Predictor of CKD are preoperative renalfunction (OR:0.92),cancer surgery (OR:8.93),AKI (OR10.9).
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
| 2017 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 01 | Day |
Other
Other related information
Cohort study
retrospective study
Between June 1, 2013 and December 31, 2015
Management information
Registered date
| 2017 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034264
