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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011927 |
Receipt No. | R000013925 |
Scientific Title | Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the cardiovascular surgery |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2016/12/27 |
Basic information | ||
Public title | Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the cardiovascular 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 cardiovascular surgery | |
Scientific Title:Acronym | Usefulness of creatinine reduction ratio. | |
Region |
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Condition | |||
Condition | Cardiovascular surgical patient | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | I include patients who were performed operation as cardiac surgery with cardiopulmonary bypass. | |||
Key exclusion criteria | Patients under 18 years old are excluded. | |||
Target sample size | 250 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Yokohama City University Hospital Department of Anesthesiology |
Institute | |
Department |
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 | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
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Other | |
Other related information | No patients were collected.
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013925 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |