UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014588 |
|---|---|
| Receipt number | R000016973 |
| Scientific Title | Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery |
| Date of disclosure of the study information | 2014/07/18 |
| Last modified on | 2015/08/20 14:27:46 |
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Basic information
Public title
Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery
Acronym
Usefulness of creatinine reduction ratio.
Scientific Title
Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery
Scientific Title:Acronym
Usefulness of creatinine reduction ratio.
Region
| Japan |
Condition
Condition
Open heart surgery
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Considered as an indicator of renal failure perioperative rate of change of the Cr value of preoperative and postoperative Cr value, to evaluate the usefulness as a predictor of AKI development.
Basic objectives2
Others
Basic objectives -Others
I diagnosed with acute kidney injury patients with creatinine rose to 1.5-fold increase or 0.3mg/dl or more than the reference value within 48 hours after surgery. Consider about what to make earlier prediction of renal injury by making a correction of creatinine and creatinine moisture balance rate of change, weight change, due to changes in urea nitrogen.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation for usefulness as a predictor of AKI creatinine value rate of change. Create the Area Under the Curve, to determine the reliability of the predictor.
Key secondary outcomes
By correcting the Cr value using fluid balance, weight change, urea nitrogen value of the immediate post-operative (BUN), it should be considered the possibility of early diagnosis of AKI.
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
I include patients who were performed operation as thoracic or abdominal surgery (liver resection, pancreaticoduodenectomy, and esophageal cancer resection).
Key exclusion criteria
Patients under 18 years old are excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University Hospital
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL
0457872800
shunty5323@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takakii |
Organization
Yokohama City University Hospital
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL
0457872800
Homepage URL
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University Hospital Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital Department of Anesthesiology
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 18 | 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
Patients who developed AKI were very small sample size, so protocol required to improve.
Therefore, this current research was ceased.
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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Whether creatinine reduction ratio associated kidney injury.
Management information
Registered date
| 2014 | Year | 07 | Month | 18 | Day |
Last modified on
| 2015 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016973
