UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045020 |
|---|---|
| Receipt number | R000051415 |
| Scientific Title | Measuring concentration of serum syndecan-1 to assess vascular endothelial glycocalyx injury during hemodialysis |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2021/07/30 20:52:33 |
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Basic information
Public title
Measuring concentration of serum syndecan-1 to assess vascular endothelial glycocalyx injury during hemodialysis
Acronym
Measuring concentration of serum syndecan-1 to assess vascular endothelial glycocalyx injury during hemodialysis
Scientific Title
Measuring concentration of serum syndecan-1 to assess vascular endothelial glycocalyx injury during hemodialysis
Scientific Title:Acronym
Measuring concentration of serum syndecan-1 to assess vascular endothelial glycocalyx injury during hemodialysis
Region
| Japan |
Condition
Condition
Chronic Renal Failure/hemodialysis
Classification by specialty
| Nephrology | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to assess endothelial injury using serum syndecan-1 as an endothelial glycocalyx injury marker in patients who underwent hemodialysis. Additionally, the present study also examined the medication type and factors that influence concentration of syndecan-1.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients' baseline characteristics are presented as median and interquartile range (IQR) for continuous variables, and frequency and proportion for categorical variables. For the primary analysis, a mixed effect model was used to assess the change in syndecan-1 levels with hemodialysis.
Key secondary outcomes
The difference in syndecan-1 levels before and after hemodialysis in the anticoagulant subgroup was confirmed using paired t-test. A multivariable linear regression analysis was performed to compare the change in syndecan-1 levels before/after hemodialysis and treatment with anticoagulants. The covariates in the regression model were age, sex, dry weight, and dialysis period. In another model, dry weight and dialysis period were simultaneously incorporated into the linear regression model to evaluate the effect of factors during dialysis on levels of syndecan-1. An interaction term was included in the model to confirm the effect of modification of dry weight and dialysis period on the change in levels of syndecan-1. If the interaction term was statistically significant, the effect of dialysis period (or dry weight) on syndecan-1 was determined to be modified by dry weight (or dialysis period). A two-sided P < 0.05 was considered to be statistically significant. Because the test is exploratory and because of concerns about low statistical power, the interaction was evaluated with a two-sided P < 0.1. R version 4.1.0 was used for statistical analyses (www.r-project.org).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent hemodialysis at the Gifu University Hospital between March 2017 and December 2019 were enrolled in the study.
Key exclusion criteria
Patients aged <20 years, died, underwent plasma apheresis, plasma exchange and double filtration plasma therapy, and who had not maintained the dry weight were excluded from the analysis.
Target sample size
145
Research contact person
Name of lead principal investigator
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University Graduate School of Medicine
Division name
Emergency and Disaster Medicine
Zip code
501-1194
Address
1-1Yanagido, Gifu
TEL
058-230-6448
hideshi@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University Graduate School of Medicine
Division name
Emergency and Disaster Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6448
Homepage URL
hideshi@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Department of Emergency and Disaster Medicine, Gifu University Graduate School of Medicine
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
The Medical Ethics Committee of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-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
| 2024 | Year | 01 | 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
145
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center, retrospective, observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051415
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