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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034796
Receipt No. R000039685
Official scientific title of the study Clinical significance of urinary L-FABP in patients transferred to the critical care center.
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/07

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Basic information
Official scientific title of the study Clinical significance of urinary L-FABP in patients transferred to the critical care center.
Title of the study (Brief title) Urinary L-FABP trends in the emergency center
Region
Japan

Condition
Condition sepsis, brain bleeding, kidney injury, trauma, heart failure
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Psychosomatic Internal Medicine Infectious disease
Geriatrics Surgery in general Obsterics and gynecology
Orthopedics Neurosurgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure liver-type fatty acid-binding protein (L-FABP) levels in urine using a rapid semiquantitative assay kit in the emergency department and to investigate whether the onset of acute kidney injury (AKI) after hospitalization can be predicted.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome was the onset of AKI.
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 The study participants included 200 consecutive patients who were transported to the emergency and critical care center and underwent insertion of a urethral catheter.
Key exclusion criteria The exclusion criteria were patients below 18 years of age, patients on maintenance dialysis, patients who underwent kidney transplant, patients for whom do not attempt resuscitation (DNAR) when hospitalized was ordered, and patients whose in-hospital duration is below 48 hr.
Target sample size 200

Research contact person
Name of lead principal investigator Ginga Suzuki
Organization Toho University Omori Medical Center
Division name Critical Care and Emergency Center
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 0337624151
Email ginga.suzuki@med.toho-u.ac.jp

Public contact
Name of contact person Ginga Suzuki
Organization Toho University Omori Medical Center
Division name Critical Care and Emergency Center
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 0337624151
Homepage URL
Email ginga.suzuki@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Toho University Omori Medical Center
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 11 Month 07 Day

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 31 Day
Anticipated trial start date
2018 Year 09 Month 01 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 None.

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039685

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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