UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004503 |
|---|---|
| Receipt number | R000005383 |
| Scientific Title | Evaluation of biomarkers of acute kidney injury (AKI) in the ICU population. |
| Date of disclosure of the study information | 2010/11/08 |
| Last modified on | 2018/02/01 11:31:35 |
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Basic information
Public title
Evaluation of biomarkers of acute kidney injury (AKI) in the ICU population.
Acronym
Evaluation of biomarkers of acute kidney injury (AKI) in the ICU population.
Scientific Title
Evaluation of biomarkers of acute kidney injury (AKI) in the ICU population.
Scientific Title:Acronym
Evaluation of biomarkers of acute kidney injury (AKI) in the ICU population.
Region
| Japan |
Condition
Condition
acute kidney injury
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The biomarkers including serum/ urinary creatinine, cystatine C, Albumin, NGAL, KIM-1, IL-18, Angiopoietin-1/-2, VEGF, sFlt-1, Vasohibin-1, SVBP, GDF-15, and urinary NAG and L-FABP are measured in an adult ICU population. We examine whether these biomarkers are related to the prediction of the development and the severity of AKI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the development of AKI and serum/ urinary biomarkers.
Key secondary outcomes
1)maximum RIFLE/AKIN class, 2) necessity of renal replacement therapy,3)renal function discharging the ICU, 4)ICU stay, 5)mortality, of AKI patients.
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
An adult ICU population at the Okayama University Hospital entered by surgical operation, hemorrhage, infection, shock, respiratory failure, brain disorder, renal disorder, collagen disease, endocrinal disease, neural disorder, allergic disorder, blood disorder, metabolic disorder, trauma, burn injury, et. al.
Key exclusion criteria
The patients already performing renal replacement therapy by end-stage renal disease.
The patients that informed consent was obtained.
Minority (under 20 years old)
The patients that was discharged ICU after entering ICU for 24 hours.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Maeshima |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama-city, 700-8558, Japan
TEL
086-235-7235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Maeshima |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama-city, 700-8558, Japan
TEL
086-235-7235
Homepage URL
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Medicine and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The urinary levels of prostaglandin E2 (PGE2), PGI2 metabolite (2,3-dinor-6-OXO-PGF1 alfa), thromboxane A2 (TXA2) metabolite (11-dehydro-TXB2) were determined.
Of the 93 patients, 24 developed AKI (AKIN criteria). Overall, the ratio of the level of serum Cr on Day 1 after ICU admission to that observed at baseline positively correlated with the urinary 2,3-dinor-6-OXO-PGF1alfa /Cr (r = 0.57, p < 0.0001) and 11-dehydro-TXB2/Cr (r = 0.47, p < 0.0001) ratios. In 16 cases of de novo AKI, the urinary 2,3-dinor-6-OXO-PGF1 alfa /Cr and 11-dehydro-TXB2/Cr values were significantly elevated compared with that observed in the non-AKI group. The urinary 2,3-dinor-6-OXO-PGF1 alfa /Cr ratio exhibited the best diagnostic and predictive performance among the prostanoid metabolites according to the receiver operating characteristic (ROC) analysis [ROC-area under the curve (AUC): 0.75
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
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
The biomarkers including serum/ urinary creatinine, cystatine C, Albumin, NGAL, KIM-1, IL-18, Angiopoietin-1/-2, VEGF, sFlt-1, Vasohibin-1, SVBP, GDF-15, and urinary NAG and L-FABP are measured in an adult ICU population. We examine whether these biomarkers are related to the prediction of the development and the severity of AKI.
Management information
Registered date
| 2010 | Year | 11 | Month | 04 | Day |
Last modified on
| 2018 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005383
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