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Clinical Trials/NCT04416971
NCT04416971
Unknown
Not Applicable

Clinical Values of Mature Fistulas in Hemodialysis

Shanghai Zhongshan Hospital1 site in 1 country100 target enrollmentAugust 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodialysis Access Failure
Sponsor
Shanghai Zhongshan Hospital
Enrollment
100
Locations
1
Primary Endpoint
AVF patency
Last Updated
5 years ago

Overview

Brief Summary

The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.

Registry
clinicaltrials.gov
Start Date
August 20, 2020
End Date
November 20, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Bo Shen

Principal Investigator

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

  • underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital, Fudan University

Exclusion Criteria

  • with malignancies
  • not followed-up at Zhongshan Hospital, Fudan University

Outcomes

Primary Outcomes

AVF patency

Time Frame: June 2020 to June 2021

A functional AVF was defined as allowing at least six adequate HD sessions without any AVF-related complications. Primary AVF patency was defined as the interval from HD initiation via a functional AVF to any intervention designed for maintenance or reestablishment of AVF function, AVF failure, or study end, whichever occurred first, and secondary AVF patency was defined as the interval from HD initiation via an AVF until the termination of HD via AVF due to any cause, regardless of the number of subsequent interventions.

Secondary Outcomes

  • Abandonment without use, infection, and other complications of AVF creation.(June 2020 to June 2021)

Study Sites (1)

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