UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047237 |
|---|---|
| Receipt number | R000053850 |
| Scientific Title | Usefulness of mean of 1h-CrCl and UNCl for estimating GFR in children requires intensive care: renal registry for children receiving intensive care |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/03/23 10:13:41 |
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Basic information
Public title
Usefulness of mean of 1h-CrCl and UNCl for estimating GFR in children requires intensive care: renal registry for children receiving intensive care
Acronym
CrUNCl-PNICU
Scientific Title
Usefulness of mean of 1h-CrCl and UNCl for estimating GFR in children requires intensive care: renal registry for children receiving intensive care
Scientific Title:Acronym
CrUNCl-PNICU
Region
| Japan |
Condition
Condition
Diseases that require intensive care
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of the mean of creatinine clearance (CrCl) and urea clearance (UNCl) examined over 1-h urine collection period (1h-CrUNCl) for estimating GFR among children receiving intensive care. To investigate the long-term renal prognosis in this patient population.
Basic objectives2
Others
Basic objectives -Others
examination of the accuracy for a testing method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between 1h-CrUNCl and inulin clearance
Key secondary outcomes
1. Correlation of 1h-CrCl, 1h-UNCl, eGFR formulae with inulin clearance
2. long term kidney function
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 18 years or younger who are admitted to pediatric/neonatal intensive care unit (PICU/NICU) in Kitasato University Hospital during the study period
Key exclusion criteria
1. Patients who are unable to urinate voluntarily and who do not need an indwelling urinary catheter in clinical practice.
2. Patients with difficult blood draws.
3. Patients who do not have transvenous routes for inulin infusion.
4. Anuric patients.
5. Patients with a history of allergic reactions or hypersensitivity to inulin products.
6. Patients who declined to participate in the study
7. Patients deemed to be inappropriate for participation by their physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | OKUDA |
Organization
Kitasato University School of Medicine
Division name
Department of Pediatrics
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
okuda@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuda |
Organization
Kitasato University School of Medicine
Division name
Department of Pediatrics
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
Homepage URL
okuda@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-8111
rinrib@med.kitasato-u.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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inulin clearance, which is the gold standard for GFR measurement, is used to measure GFR as a control.
After admission to the PICU/NICU, or returning to the PICU/NICU after surgery, and if the general condition is stable enough to perform the inulin clearance test, participants receive the inulin clearance test based on the prescribed protocol. Inulin clearance and 1h-CrUNCl are calculated using the collected blood and urine samples.
Blood tests are also performed during the observation period to monitor long-term kidney function.
Management information
Registered date
| 2022 | Year | 03 | Month | 21 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053850
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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