UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049764 |
|---|---|
| Receipt number | R000056334 |
| Scientific Title | Risk factors for incidence of cardiac surgery associated acute kidney injury(AKI) and impact of hemolysis on the incedence of AKI. |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2022/12/13 16:19:33 |
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Basic information
Public title
Risk factors for incidence of cardiac surgery associated acute kidney injury(AKI) and impact of hemolysis on the incedence of AKI.
Acronym
Risk factors for incidence of cardiac surgery associated acute kidney injury(AKI) and impact of hemolysis on the incedence of AKI.
Scientific Title
Risk factors for incidence of cardiac surgery associated acute kidney injury(AKI) and impact of hemolysis on the incedence of AKI.
Scientific Title:Acronym
Risk factors for incidence of cardiac surgery associated acute kidney injury(AKI) and impact of hemolysis on the incedence of AKI.
Region
| Japan |
Condition
Condition
acute kidney injury
Classification by specialty
| Nephrology | Anesthesiology | Cardiovascular surgery |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the causative agent of perioperative acute renal failure
caused by cardiopulmonary bypass.
Basic objectives2
Others
Basic objectives -Others
Hemolysis has been considered to be one of the causes of acute kidney injury due to cardiac surgery under cardiopulmonary bypass. By collecting measurable factors and clinical data from perioperative blood and urine samples, we attempted to identify factors involved in the development of acute kidney injury during cardiopulmonary bypass and to construct a model for predicting acute kidney injury based on these factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of acute kidney injury assessed by KDIGO classification Stage 1 or higher up to 3 days after surgery.
Newly started hemodialysis.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients receiving cardiac surgery under cardiopulmonary bypass.
Patients should be ASA physical status 4 or under.
Key exclusion criteria
chronic hemodialysis
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Toda |
Organization
Kawasaki Medical School
Division name
Anesthesiology and Intensive Care Medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki-shi Okayama Japan
TEL
086-462-1111
today@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Toda |
Organization
Kawasaki Medical School
Division name
Anesthesiology and Intensive Care Medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki-shi Okayama Japan
TEL
086-462-1111
Homepage URL
today@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki-shi Okayama Japan
Tel
086-462-1111
today@med.kawasaki-m.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
| 2023 | Year | 01 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | 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
no special instruction
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056334
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