UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of biomarkers of acute kidney injury (AKI) in the ICU population.
Title of the study (Brief title)	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	Yohei Maeshima
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Medicine and Clinical Science
Address	2-5-1 Shikata-cho, Kitaku, Okayama-city, 700-8558, Japan
TEL	086-235-7235
Email

Public contact
Name of contact person	Yohei Maeshima
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Medicine and Clinical Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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
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/icdr_e/ctr_view.cgi?recptno=R000005383