Clinical Values of Mature Fistulas in Hemodialysis

August 16, 2020 updated by: Bo Shen, Shanghai Zhongshan Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

  • aged 18 years and older
  • underwent initial upper-extremity AVF creation for incident HD at our hospital
  • divided into mature/immature AVF groups according to the AVF status on HD initiation

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mature AVF
Patients initiate HD with mature AVF.
Procedure: AVF puncture
For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.
immature AVF
Patients initiate HD with immature AVF.
Procedure: AVF puncture
For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
June 2020 to June 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abandonment without use, infection, and other complications of AVF creation.
Time Frame: June 2020 to June 2021
Abandonment without use, infection, and other complications of AVF creation.
June 2020 to June 2021

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Bo Shen, MD, Fudan University

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)

August 20, 2020

Primary Completion (Anticipated)

August 20, 2021

Study Completion (Anticipated)

November 20, 2021

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mature Fistulas

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

product manufactured in and exported from the U.S.

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.

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