UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of early detection of acute kidney injury using urinary L-type fatty acid binding protein (L-FABP)
Title of the study (Brief title)	Early detection of acute kidney injury by L-FABP
Region	Japan

Condition
Condition	acute kidney injury
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By measuring L-FABP, we diagnose acute renal injury earlier than existing diagnostic criteria (serum creatinine or urine volume)
Basic objectives2	Others
Basic objectives -Others	Differences in the cause of acute renal injury such as trauma and intrinsic relation with L-FABP
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of variation of L-FABP and variation of creatinine in two groups with or without AKI onset
Key secondary outcomes

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	A-line and balloon insertion patient when entering ICU
Key exclusion criteria	NO
Target sample size	400

Research contact person
Name of lead principal investigator	Hideki Asai
Organization	Nara Medical University
Division name	Department of Emergency and Critical Care
Address	840 Shijo-Cho, Kashihara, Nara, Japan
TEL	0744-22-3051
Email	asaih@naramed-u.ac.jp

Public contact
Name of contact person	Hideki Asai
Organization	Nara Medical University
Division name	Department of Emergency and Critical Care
Address	840 Shijo-Cho, Kashihara, Nara, Japan
TEL	0744-22-3051
Homepage URL
Email	asaih@naramed-u.ac.jp

Sponsor
Institute	Department of Emergency and Critical Care, Nara Medical University
Institute
Department

Funding Source
Organization	Department of Emergency and Critical Care, Nara Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 15 Day
Anticipated trial start date	2018 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cohort study retrospective study

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036489