UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031973 |
|---|---|
| Receipt number | R000036489 |
| Scientific Title | Study of early detection of acute kidney injury using urinary L-type fatty acid binding protein (L-FABP) |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/03/29 13:07:16 |
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Basic information
Public title
Study of early detection of acute kidney injury using urinary L-type fatty acid binding protein (L-FABP)
Acronym
Early detection of acute kidney injury by L-FABP
Scientific Title
Study of early detection of acute kidney injury using urinary L-type fatty acid binding protein (L-FABP)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hideki Asai |
Organization
Nara Medical University
Division name
Department of Emergency and Critical Care
Zip code
Address
840 Shijo-Cho, Kashihara, Nara, Japan
TEL
0744-22-3051
asaih@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Asai |
Organization
Nara Medical University
Division name
Department of Emergency and Critical Care
Zip code
Address
840 Shijo-Cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
asaih@naramed-u.ac.jp
Sponsor or person
Institute
Department of Emergency and Critical Care, Nara Medical University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036489
