NCT07436559

Brief Summary

The prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. If the arteriovenous fistula is narrowed, the dialysis effect will be poor or the dialysis will not be possible due to blockage, resulting in complications and mortality. The detection of the arteriovenous fistula must rely on the assistance of professionals. \* Is it easier for clinicians to detect arteriovenous fistula stenosis by an electronic stethoscope? This study uses an electronic stethoscope to take the hemodialysis center of Douliu District, Yunlin Branch of National Taiwan University Hospital as the experimental site. Select 30 patients who need long-term dialysis, adults (20-99 years old) who have been on dialysis for more than 3 months and have arteriovenous fistula. The experiment period lasted for 3 months, and each person received 2-3 voices per week, about 1080 voices. The main purpose is to use the electronic stethoscope and the experience of traditional professionals, hoping to detect and predict the stenosis in advance. The important key factors of vascular access stenosis in hemodialysis patients were found through regression analysis of the Albumin value and clinical data obtained from routine treatment of patients of a fixed blood test in monthly hemodialysis center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

February 22, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

Hemodialysis, Electronic Stethoscope, Arteriovenous Fistula, Regression Analysis

Outcome Measures

Primary Outcomes (1)

  • AVF stenosis

    Clinical stenosis: Diagnosed by attending nephrologist based on physical examination abnormalities (high-pitched bruit, pulsatile flow, diminished thrill) - Confirmed by Doppler ultrasound showing \>50% diameter reduction - Intervention: Percutaneous transluminal angioplasty (PTA)

    From enrollment to the end of study at 3 months

Secondary Outcomes (1)

  • Abnormal AVF sound threshold

    From enrollment to the end of study at 3 months

Interventions

The detection of the arteriovenous fistula must rely on the assistance of professionals by palpation or a conventional stethoscope. This study will investigate the detection and prediction of arteriovenous fistula stenosis in hemodialysis patients by an electronic stethoscope.

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

End stage renal disease patients received hemodialysis for more than 3 months

You may qualify if:

  • Age 20-99 years - Chronic hemodialysis ≥3 months - Functional arteriovenous fistula (AVF) - Ability to provide informed consent

You may not qualify if:

  • Arteriovenous graft (AVG) - Central venous catheter (Permcath) - Vulnerable populations unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan, 640, Taiwan

Location

MeSH Terms

Conditions

Kidney Failure, ChronicArteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

March 17, 2023

Primary Completion

June 16, 2023

Study Completion

September 30, 2023

Last Updated

February 27, 2026

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations