UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024926 |
|---|---|
| Receipt number | R000028676 |
| Scientific Title | Blood Purification Therapy and Endothelial Disorder |
| Date of disclosure of the study information | 2017/11/21 |
| Last modified on | 2024/05/29 11:41:07 |
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Basic information
Public title
Blood Purification Therapy and Endothelial Disorder
Acronym
Blood Purification Therapy and Endothelial Disorder
Scientific Title
Blood Purification Therapy and Endothelial Disorder
Scientific Title:Acronym
Blood Purification Therapy and Endothelial Disorder
Region
| Japan |
Condition
Condition
Chronic Renal Failure, Acute Kindey Injury
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure plasma Syndecan-1 and Endocan concentration before/after blood purification therapy
Basic objectives2
Others
Basic objectives -Others
To assess endothelial disorder
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To measure plasma Syndecan-1 and Endocan concentration
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received blood purification therapy in our institute.
Key exclusion criteria
Patients who are below 20-years-old.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu Univeersity Graduate School of Medicine
Division name
Emergency and Disaster Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6448
hideshi@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Okamoto |
Organization
Gifu Univeersity Graduate School of Medicine
Division name
Emergency and Disaster Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6448
Homepage URL
edm2@gifu-u.ac.jp
Sponsor or person
Institute
Department of Emergency and Disaster Medicine, Gifu University Graduate School of Medicine
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Graduate School of Medicine
Address
1-1 Yanagido
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
岐阜大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fmed.2021.791309/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fmed.2021.791309/full
Number of participants that the trial has enrolled
145
Results
The median HD period and time were 63 months and 3.7h, respectively. The serum SDC1 concentration significantly increased before HD to after HD (P<0.001). Treatment with anticoagulant nafamostat mesylate inhibited HD-induced increase in the levels of serum SDC1 in comparison to unfractionated heparin. The reduction in the amount of body fluid removed and dialysis time inhibited the change in the SDC1 levels before and after HD.
Results date posted
| 2024 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We finally enrolled 145 patients with a median age of 66 years. The median dialysis period and time were 63 months and 3 h and 45 min, respectively. The most common primary illness was diabetic nephropathy, which was observed in 37 patients (25.5%). The number of patients who underwent hemodialysis and hemodiafiltration was 133 (91.7%) and 12 (8.3%), respectively. Anticoagulation agents, such as unfractionated heparin, low-molecular-weight heparin, and nafamostat mesylate, were administered to 101, 24, and 20 patients, respectively. The median Kt/V-value, an index of dialysis efficiency, was 1.20.
Participant flow
This was a single-center, retrospective, observational study conducted at the Gifu University Hospital, affiliated to Gifu University, Gifu, Japan. Patients, who underwent hemodialysis at the Gifu University Hospital between March 2017 and December 2019 and whose dry weight remained unchanged in the last three examinations, were enrolled. Patients aged <20 years, who underwent plasma apheresis, plasma exchange, and double filtration plasma therapy, and had not maintained their dry weight were excluded. Finally, data from 145 patients were obtained and analyzed.
Adverse events
None
Outcome measures
The serum syndecan-1 concentration significantly increased (P<0.001) after hemodialysis. The concentration of serum syndecan-1 significantly increased after hemodialysis in patients who received unfractionated heparin and low-molecular-weight heparin however, the concentration of syndecan-1 was not significantly different before and after hemodialysis in those who received nafamostat mesylate. Additionally, according to the multivariable regression analysis after adjusting for age, sex, dry weight, and dialysis period, the treatment with nafamostat mesylate inhibited the increase in the concentration of serum syndecan-1 during hemodialysis compared to treatment with unfractionated heparin and low-molecular-weight heparin. Interestingly, there was no strong relationship between the syndecan-1 levels and blood pressure, vascular access, cardiovascular disease, and primary disease before and after dialysis. The relationship between the concentration variability of syndecan-1 and the dialysis condition, including the dialysis time and the amount of body fluid removed, was confirmed. The amount of body fluid removal was corrected by the dry weight. The dialysis time and change in concentration of syndecan-1 showed a positive correlation (P=0.033), but there was no significant association (P=0.111) between the amount of body fluid removed and the syndecan-1 concentration changes. Next, we examined the modifying effect of the amount of body fluid removed on the association between the change in the concentration of syndecan-1 and dialysis time. The change in the syndecan-1 concentration before and after hemodialysis increased with respect to enhanced removal of body fluids and prolonged dialysis time (P for interaction=0.063). However, the change in the syndecan-1 concentration before and after hemodialysis decreased with respect to a decrease in the amount of body fluid removed and shortened dialysis time.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028676
