Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF

June 3, 2020 updated by: Bo Shen, Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • with malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AVF patency rate
Time Frame: 6 months
AVF patency rate
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AVF complication
Time Frame: 12 months
AVF complication
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AVF-assessment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Access Complication

Clinical Trials on Intensified Monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe