Clinical Utility of Hemodialysis Vascular Sound Index for Prediction of Acute Vascular Access Failure: A Multicenter Prospective Observational Study

Validation of the Predictive Ability of the Hemodialysis Vascular Sound Index for Acute Vascular Access Failure: A Multicenter Prospective Observational Study - HVSI-VA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061865

Enrollment

1000

Registered

2026-06-11

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Native arteriovenous fistula (AVF) in maintenance hemodialysis patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing maintenance hemodialysis Patients with native arteriovenous fistula (AVF) Patients undergoing routine vascular access ultrasound examinations at participating institutions

Exclusion criteria

Exclusion criteria: Patients with arteriovenous grafts (AVG) Patients using central venous catheters Patients considered inappropriate by the investigators

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactYasumasa Hitomi

Tojinkai Hospital Department of Medical Technology

hitomi.y@tojinkai.jp0756221991

Outcome results