UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061865 |
|---|---|
| Receipt number | R000070792 |
| Scientific Title | Validation of the Predictive Ability of the Hemodialysis Vascular Sound Index for Acute Vascular Access Failure: A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 11:22:30 |
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Basic information
Public title
Clinical Utility of Hemodialysis Vascular Sound Index for Prediction of Acute Vascular Access Failure: A Multicenter Prospective Observational Study
Acronym
HVSI-VA Study
Scientific Title
Validation of the Predictive Ability of the Hemodialysis Vascular Sound Index for Acute Vascular Access Failure: A Multicenter Prospective Observational Study
Scientific Title:Acronym
HVSI-VA
Region
| Japan |
Condition
Condition
Native arteriovenous fistula (AVF) in maintenance hemodialysis patients
Classification by specialty
| Nephrology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether the Hemodialysis Vascular Sound Index (HVSI) can predict acute vascular access failure, including thrombosis, emergency vascular access intervention therapy (VAIVT), and emergency vascular access reconstruction, in maintenance hemodialysis patients. In addition, the relationship between HVSI and ultrasonographic findings, including flow volume, resistance index, and minimum vessel diameter, will be investigated.
Basic objectives2
Others
Basic objectives -Others
Prognostic prediction and diagnostic performance evaluation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of acute vascular access failure within 30 days after HVSI measurement, defined as thrombosis, emergency vascular access intervention therapy (VAIVT), or emergency vascular access reconstruction.
Key secondary outcomes
Association between HVSI and flow volume (FV)
Association between HVSI and resistance index (RI)
Association between HVSI and minimum diameter of the culprit lesion
Association between HVSI and degree of stenosis
Association between HVSI and presence of bifurcation lesions
Diagnostic performance of HVSI for prediction of acute vascular access failure, including ROC analysis, sensitivity, specificity, and area under the curve (AUC)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing maintenance hemodialysis
Patients with native arteriovenous fistula (AVF)
Patients undergoing routine vascular access ultrasound examinations at participating institutions
Key exclusion criteria
Patients with arteriovenous grafts (AVG)
Patients using central venous catheters
Patients considered inappropriate by the investigators
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Hitomi |
Organization
Tojinkai Hospital
Division name
Department of Medical Technology
Zip code
6128026
Address
83-1 Igacho, Momoyama-cho, Fushimi-ku, Kyoto, Japan
TEL
0756221991
hitomi.y@tojinkai.jp
Public contact
Name of contact person
| 1st name | Yasumasa |
| Middle name | |
| Last name | Hitomi |
Organization
Tojinkai Hospital
Division name
Department of Medical Technology
Zip code
6128026
Address
83-1 Igacho, Momoyama-cho, Fushimi-ku, Kyoto, Japan
TEL
0756221991
Homepage URL
hitomi.y@tojinkai.jp
Sponsor or person
Institute
Tojinkai Hospital
Institute
Department
Personal name
Yasumasa Hitomi
Funding Source
Organization
Tojinkai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tojinkai Hospital
Address
83-1 Igacho, Momoyama-cho, Fushimi-ku, Kyoto, Japan
Tel
0756221991
hitomi.y@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
特定医療法人桃仁会病院（京都府）
どい腎臓内科透析クリニック（広島県）
新生会第一病院（愛知県）
日鋼記念病院（北海道）
大川VA透析クリニック（大阪府）
東葛クリニック病院（千葉県）
クレドさとうクリニック（千葉県）
高橋内科クリニック（福岡県）
新生会平針記念クリニック（愛知県）
埼玉医科大学総合医療センター（埼玉県）
JA長野厚生連南長野医療センター篠ノ井総合病院（長野県）
KKR高松病院（香川県）
つくばセントラル病院（茨城県）
佐藤循環器科内科（愛媛県）
弘愈会ひまわりクリニック（千葉県）
天童温泉矢吹クリニック（山形県）
南千住病院（東京都）
新生会 鳴海クリニック（愛知県）
桃仁会附属診療所（京都府）
からすま透析クリニック（京都府）
かつら透析クリニック（京都府）
向島クリニック（京都府）
計行会高橋計行クリニック（大阪府）
計行会第2髙橋計行クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 11 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study in hemodialysis patients. HVSI will be measured during routine vascular access ultrasound examinations, and its association with acute vascular access failure within 30 days will be evaluated. No intervention will be performed.
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070792
