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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004503
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Medicine and Clinical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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