UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056433 |
|---|---|
| Receipt number | R000064486 |
| Scientific Title | The Accuracy of the Hemodialysis Vascular Sound Index in Detecting Vascular Access Stenosis and Reduced Flow Volume. |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2024/12/12 12:58:52 |
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Basic information
Public title
The Accuracy of the Hemodialysis Vascular Sound Index in Detecting Vascular Access Stenosis and Reduced Flow Volume.
Acronym
Diagnostic Accuracy of the Haemodialysis Vascular Sound Index
Scientific Title
The Accuracy of the Hemodialysis Vascular Sound Index in Detecting Vascular Access Stenosis and Reduced Flow Volume.
Scientific Title:Acronym
Diagnostic Accuracy of the Haemodialysis Vascular Sound Index
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology | Vascular surgery | Urology |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Hemodialysis Vascular Sound Index (HVSI), derived from vascular murmur analysis, may provide a simple, objective alternative. This study evaluates the diagnostic performance of the HVSI in detecting VA stenosis and reduced flow volume (FV).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between HVSI and flow volume measured by vascular ultrasound.
Calculation of the cut-off value for diagnosing VA stenosis using HVSI and its accuracy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This prospective case-control study included adult patients who underwent hemodialysis and VA interventional treatment (VAIVT) at Tojinkai Hospital between February 1, 2023, and March 31, 2024.
Key exclusion criteria
Patients who use artificial blood vessels for vascular access.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Hitomi |
Organization
Tojinkai Hospital
Division name
Medical Technology Department, Clinical Engineering Department
Zip code
6128026
Address
83-1 Iga, Momoyamacho, Fushimi-ku, Kyoto City
TEL
0756221991
hitomi.y@tojinkai.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tojinkai Hospital
Division name
Data Science Department
Zip code
6128026
Address
83-1 Iga, Momoyamacho, Fushimi-ku, Kyoto City
TEL
0756221991
Homepage URL
key.9629@gmail.com
Sponsor or person
Institute
Tojinkai Hospital
Institute
Department
Personal name
Naoki Suzuki
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tojinkai Hosupital Ethics Review Committee
Address
83-1 Iga, Momoyamacho, Fushimi-ku, Kyoto City
Tel
0756221991
suzuki@tojinkai.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 | 12 | Month | 12 | 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
202
Results
HVSI showed a significant correlation with FV (R^2 = 0.58) and RI (R^2 = 0.32). When the threshold for FV was 500 mL/min or less, 400 mL/min or less , and 350 mL/min or less, the sensitivity, specificity, and AUC of the HVSI were 86.3% to 94.4%, 78.7% to 82.9%, and 0.90 to 0.94, respectively. The diagnostic accuracy was higher for non-branching vessels.
Results date posted
| 2024 | Year | 12 | Month | 12 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 03 | Day |
Other
Other related information
HVSI showed significant correlations with FV (R^2= 0.58) and RI (R^2 = 0.32). For FV thresholds 500 mL/min or less, 400 mL/min or less, or 350 mL/min or less, HVSI showed sensitivities of 86.3-94.4%, specificities of 78.7-82.9%, and AUCs of 0.90-0.94. Diagnostic accuracy was higher in non-bifurcated vessels.
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064486
