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 | 2025/12/07 14:18:23 |
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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 | Shunsuke |
| Middle name | |
| Last name | Takaki |
Organization
Yokohama City University Hospital
Division name
Department of Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL
0457872800
shun5323@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Takaki |
Organization
Yokohama City University Hospital
Division name
Department of Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL
0457872800
Homepage URL
shun5323@yokohama-cu.ac.jp
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
Yokohama City University Ethics Committee for Life Science and Medical Research Involving Human Subjects
Address
3-9 Fukuura Kanazawaku Yokohama
Tel
0457872918
shun5323@yokohama-cu.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
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
https://www.mdpi.com/2077-0383/13/1/9
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/13/1/9
Number of participants that the trial has enrolled
213
Results
We analyzed 213 patients AKI 94, non AKI 119 after excluding 127 cases from 340 cardiac surgery patients 2009-2013. Postoperative CRR predicted AKI with an AUC of 0.725, and CRR <15% improved specificity to 48.7%. CRR reduction, preoperative CKD, and cross clamp time were associated with AKI, while multivariable analysis identified CRR <20% OR 5.1 and surgery time as independent predictors. New CKD at 3-6 months was higher in the AKI group 36.0% vs 8.9%.
Results date posted
| 2025 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 19 | Day |
Baseline Characteristics
A total of 213 patients who underwent elective cardiac surgery at Yokohama City University Hospital between 2009 and 2013 were included in the study. Preoperative data collected included patient background factors such as age, hypertension, diabetes, renal function, cardiac disease, and respiratory function.
Participant flow
Patient information was extracted from the electronic medical records, and patients with insufficient data were excluded to determine the study population.
Adverse events
As this was an observational study, no adverse events were observed.
Outcome measures
Intraoperative data included anesthesia time, operative time, cardiopulmonary bypass time, aortic cross-clamp time, presence or absence of blood transfusion, and pre- and postoperative serum creatinine levels. CRR was calculated as the percentage change in creatinine before and after surgery using the formula: (postoperative creatinine - preoperative creatinine) / preoperative creatinine x 100%. The definition of AKI followed the AKIN and RIFLE criteria, using an increase in creatinine within 48 hours postoperatively (>= 0.3 mg/dL or >= 150% increase) (Mehta RL et al., 2007). CKD was defined as an eGFR < 60 mL/min/1.73 m2 using an equation adapted for the Japanese population (Yuzo Watanabe et al., 2015).
Patients were divided into the AKI-CS group and the non-AKI-CS group to identify risk factors for AKI onset, and the optimal CRR cut-off value was determined using a receiver operating characteristic (ROC) curve. For long-term evaluation, eGFR at 6 months postoperatively was assessed to investigate the impact of CRR and AKI-CS occurrence on CKD. In the multivariate analysis, the final selection of confounding variables was performed using the Akaike's information criterion (AIC) stepwise procedure. A p-value of < 0.05 was considered statistically significant.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 15 | Day |
Other
Other related information
Whether creatinine reduction ratio associated kidney injury.
Management information
Registered date
| 2014 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016973
