UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024155 |
|---|---|
| Receipt number | 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 12:01:20 |
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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
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
c-mitaka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027140
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
