Clinical Values of Mature Fistulas in Hemodialysis

• Conditions: Hemodialysis Complication; Hemodialysis Access Failure
• Interventions: Procedure: AVF puncture

• Registration Number: NCT04416971
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-16
• Last Update Posted: 2020-08-18
• Study Start: 2020-08-20
• Primary Completion: 2021-08-20
• Study Completion: 2021-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
immature AVF	AVF puncture	Patients initiate HD with immature AVF.
mature AVF	AVF puncture	Patients initiate HD with mature AVF.

Primary Outcome Measures

Name	Time	Method
AVF patency	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 Outcome Measures

Name	Time	Method
Abandonment without use, infection, and other complications of AVF creation.	June 2020 to June 2021	Abandonment without use, infection, and other complications of AVF creation.

Trial Locations

Locations (1)

No.180, Fenglin Road, Xuhui District; 🇨🇳 Shanghai, Shanghai, China