UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031193 |
|---|---|
| Receipt number | R000035615 |
| Scientific Title | Correlation between Urinary Biomarkers and Organ Failure in Patients with Pediatric Cardiac Surgery: Prospective Observational Studies |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2021/02/09 09:47:33 |
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Basic information
Public title
Correlation between Urinary Biomarkers and Organ Failure in Patients with Pediatric Cardiac Surgery: Prospective Observational Studies
Acronym
NGAL after pediatric cardiac surgery
Scientific Title
Correlation between Urinary Biomarkers and Organ Failure in Patients with Pediatric Cardiac Surgery: Prospective Observational Studies
Scientific Title:Acronym
NGAL after pediatric cardiac surgery
Region
| Japan |
Condition
Condition
urinary biomaker
Classification by specialty
| Nephrology | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between NGAL values and organ dysfunction after pediatric cardiac surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
NGAL at 3 hours, 6 hours, 12 hours, 1 day, 3 days after surgery
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
postoperative patients after pediatric cardiac surgery
Key exclusion criteria
dialysis patients
Patients who judged that researchers are inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakanishi |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku
TEL
08034162802
knakani@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakanishi |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku
TEL
03-3813-3111
Homepage URL
knakani@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku
Tel
03-3813-3111
knakani@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Start NGAL measurement from the Ethics Committee after approval of the test.
Management information
Registered date
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035615
| Research Plan | |
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| 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 |
