Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF

Study Overview
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Brief Summary
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Whether intensive monitoring and preemptive intervention has an positive clinical effect on arterio-venous fistula (AVF) maintenance is a new issue in hemodialysis (HD) patient management. This study aims to explore the clinical value of intensive monitoring and preemptive intervention on AVF, so to decide the best follow-up items and frequency.

Official Title
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The Clinical Value of Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF: a Random Controlled Trial

Conditions
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Vascular Access Site Occlusion, Vascular Access Malfunction, Vascular Access Complication

Intervention / Treatment
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* Other: Intensified Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients on HD with AVF in Zhongshan Hospital, Fudan University Exclusion Criteria: with malignancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Monitoring and Preemptive Intervention<br>In this group patients receive intensive monitoring and preemptive intervention. AVF surveillance refers to using non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa every month. Clinical assessment refers to monitoring for any presence of stenosis by (i) physical examination, by means of visual inspection and presence of abnormal thrill, bruit or pulse and (ii) checking for signs of access dysfunction during dialysis: difficult cannulation, increase in dynamic arterial or venous pressure, inability to achieve the prescribed dialysis blood pump flow (Qb), prolonged bleeding after needle removal, access recirculation or a drop in Kt/V. Preemptive intervention is performed as long as problems are recognized, including health education and timely surgery. | Other: Intensified Monitoring<br>* Apart from clinical assessment, use non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa, using either indicator dilution techniques or duplex ultrasound every month.<br>|
| No Intervention: Traditional Monitoring and Intervention<br>In this group patient receive traditional AVF monitoring, includes clinical assessment for any presence of stenosis by (i) physical examination, by means of visual inspection and presence of abnormal thrill, bruit or pulse and (ii) checking for signs of access dysfunction during dialysis: difficult cannulation, increase in dynamic arterial or venous pressure, inability to achieve the prescribed dialysis blood pump flow (Qb), prolonged bleeding after needle removal, access recirculation or a drop in Kt/V. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF patency rate | AVF patency rate | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF complication | AVF complication | 12 months |