Clinical Values of Mature Fistulas in Hemodialysis

Hemodialysis Complication Clinical Trial

Official title:

Clinical Values of Mature Fistulas in Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416971
• Other study ID #: Mature Fistulas
• Status: Recruiting
• Start date: August 20, 2020
• Est. completion date: November 20, 2021

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: bo shen, MD
• Phone: +86-13795307471
• Email: shen.bo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Hemodialysis Access Failure
• Hemodialysis Complication

Intervention

Procedure:
• AVF puncture
For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.

Locations

Country	Name	City	State
China	No.180, Fenglin Road, Xuhui District	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AVF patency	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.	June 2020 to June 2021
Secondary	Abandonment without use, infection, and other complications of AVF creation.	Abandonment without use, infection, and other complications of AVF creation.	June 2020 to June 2021