UMIN-CTR Clinical Trial

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
Email	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
Email	hideshi@gifu-u.ac.jp

Sponsor
Institute	Gifu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051415