CClinicalTrials.gg
Status unknownNCT04418726Updated Jun 5, 2020

Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF

An interventional study of Intensified Monitoring in Vascular Access Malfunction, Vascular Access Complication and Vascular Access Site Occlusion, sponsored by Shanghai Zhongshan Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Vascular Access Malfunction
  • Vascular Access Complication
  • Vascular Access Site Occlusion
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In context

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients on HD with AVF in Zhongshan Hospital, Fudan University

Exclusion criteria

Exclusion Criteria:

  • with malignancies
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Intensive Monitoring and Preemptive Intervention

    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

  • No intervention
    Traditional Monitoring and Intervention

    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.

Interventions

  • OtherIntensified Monitoring

    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.

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What researchers measure

Primary outcomes

  1. AVF patency rate

    AVF patency rate

    Time frame: 6 months

Secondary outcomes

  1. AVF complication

    AVF complication

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04418726
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Bo Shen (Attending Physician, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Jun 5, 2020
Start date
Jun 1, 2020 (estimated)
Primary completion
May 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jun 5, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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