UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044330 |
|---|---|
| Receipt number | R000050558 |
| Scientific Title | Cohort study in management after renal biopsy |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/11/27 10:30:13 |
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Basic information
Public title
Cohort study in management after renal biopsy
Acronym
Cohort study in management after renal biopsy
Scientific Title
Cohort study in management after renal biopsy
Scientific Title:Acronym
Cohort study in management after renal biopsy
Region
| Japan |
Condition
Condition
renal disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine appropriate fluid management after renal biopsy.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinically significant electrolyte disorder
Key secondary outcomes
Weight gain
Urine volume
Acid-base abnormalities
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
| 1 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases in which renal biopsy was performed during the period
Key exclusion criteria
Cases in which infusion therapy was not performed according to the clinical path
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Horinouchi |
Organization
Kobe University
Division name
Pediatrics
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-Ku, Kobe
TEL
0783826090
tohori@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Horinouchi |
Organization
Kobe University
Division name
Pediatrics
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-Ku, Kobe
TEL
0783826090
Homepage URL
tohori@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Kobe University Hospital clinical and translational research center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
0783826669
kansatsu@med.kobe-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00467-024-06594-0
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00467-024-06594-0
Number of participants that the trial has enrolled
61
Results
During pediatric kidney biopsy, both saline and balanced crystalloids were effective in preventing hyponatremia. Although saline infusion results in higher serum chloride concentrations and lower blood HCO3- concentrations than balanced crystalloids infusion, the clinical significance was minimal.
Results date posted
| 2024 | Year | 11 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included pediatric patients aged 1-19 years who underwent kidney biopsies.
Participant flow
This study is a single-center, non-randomized controlled trial at Kobe University Hospital, Japan, between April 2021 and March 2023.
Adverse events
None
Outcome measures
The primary outcome was the occurrence of hyponatremia (< 137 mEq/L) after a kidney biopsy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assess appropriate management after renal biopsy.
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050558
