UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024155
Receipt No. R000027140
Scientific Title Correlation between urinary biomarker and organ failure in critically ill patients
Date of disclosure of the study information 2016/10/15
Last modified on 2020/03/29 (Ver. 9)

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Basic information
Public title Correlation between urinary biomarker and organ failure
in critically ill patients
Acronym CUBIC study
Scientific Title Correlation between urinary biomarker and organ failure
in critically ill patients
Scientific Title:Acronym CUBIC study
Region
Japan

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

Objectives
Narrative objectives1 To elucidate correlation between urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration and organ failure including acute kidney injury
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between urinary NGAL concentration and organ failure
Key secondary outcomes Prediction of prognosis by changes in urinary NGAL concentration

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
90 years-old >=
Gender Male and Female
Key inclusion criteria critically ill patients
Key exclusion criteria Hemodialysis
Renal transplantation
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Chieko
Middle name
Last name Mitaka
Organization Juntendo University School of Medicine
Division name Anesthesiology and Pain Medicine
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email c-mitaka@juntendo.ac.jp

Public contact
Name of contact person
1st name Chieko
Middle name
Last name Mitaka
Organization Juntendo University School of Medicine
Division name Anesthesiology and Pain Medicine
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email c-mitaka@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Abbott Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Juntendo University Hospital
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel 03-3813-3111
Email kenkyu5858@juntendo.ac.jp

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 順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1186/s40560-0120-0428-7
Number of participants that the trial has enrolled 85
Results 
uNGAL levels, APACHE II score, SOFA score, 
and serum CRP levels were significantly higher in the 
sepsis group than in the esophagectomy group. In the 
sepsis group, uNGAL levels were significantly correlated 
with APACHE II score and SOFA score, and 7 patient developed AKI. In the esophagectomy group, uNGAL levels weresignificantly correlated with SOFA score, and no patients 
developed AKI. In a total of 85 patients, 80 patients had an abnormal value of uNGAL and only 7 patients developed 
AKI.
Results date posted
2020 Year 03 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 01 Month 10 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
2016 Year 09 Month 30 Day
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
2019 Year 08 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information No

Management information
Registered date
2016 Year 09 Month 25 Day
Last modified on
2020 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027140