Cohort Study on A Following-up System of Native Arteriovenous Fistulae

Arteriovenous Fistulae Clinical Trial

Official title:

Cohort Study on A Following-up System of Native Arteriovenous Fistulae in Chinese Patients Treated by Maintenance Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880761
• Other study ID #: 2016-019
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2019
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A cohort including more than 100 maintenance hemodialysis patients will be followed up according to a certain Following-up System of Native Arteriovenous Fistulae (AVF) prospectively. The assessment results of the Following-up System of AVF help the physicians make decisions of AVF surgery and puncture methods. The results of this study would identify the effect of the system on survival of AVF. Other 100 hemodialysis patients from other centers will be treated by routine protocol and compared to the experiment goup.

Description:

The Following-up System of AVF includes 3 stages. In the 1st stage, before AVF surgery operation, the contents of Following-up System of AVF include history, physical exam, ultrasonography detection. The assesment results will guide the methods of the AVF surgery operation. In the 2nd stage, before AVF puncture firstly and 3 months after AVF operation, the contents of Following-up System of AVF include physical exam and ultrasonography detection. The results will help the nurses and doctors make a decision of the method of AVF puncture. In the 3rd stage, during the following 2 years after AVF puncture successfully, the contents include physical exam and ultrasonography detection regularly. The adequacy of hemodialysis by using AVF will be assessed by urea clearance index (Kt/V).

The data of patients in other hemodialysis centers will be recorded and compared to the patients in experiment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Maintenance hemodialysis patients using AVF;

• Ages 18-70 years old;

• Agreement with frequent following-up.

Exclusion Criteria:

• Younger than 18 years or elder than 70 years;

• Cachexia;

• Acute renal failure;

• Exceptive life time less than 6 months;

• Pregnant or planning pregnant;

• Waiting for renal transplantation or transferring to peritoneal dialysis.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistulae
• Fistula

Intervention

Procedure:
• Assessment guiding surgery and puncture for AVF
Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF

Locations

Country	Name	City	State
China	Peking University International Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Value of Urea Clearance Index During 24 Months	As a parameter of hemodialysis adequacy, urea clearance index (Kt/V) will be detected very month. The Kt/V should be larger than 1.2 , which were regarded as being adequate in the hemodialysis session. This parameter will be tested every month and the mean value were be calculated according to the records during 24 months. Those who with Kt/V less than 1.2 for 3 times would be defined as the patient with unfunctional AVF. The values of Kt/V in unfunctional AVF patients would not be used in statistic analysis.	2 years
Primary	Number of Participants With Fistula Failure	The AVF can not be used for hemodialysis treatment 3 months after surgery, which it is defined as Primary Failure of AVF. The primary failure of AVF is regarded as the primary outcome of the patients who were followed up. The ratio of primary failure will be compared between two groups.	3 months after surgery
Secondary	Life Time of AVF	The life time of an available AVF since the AVF is functionable. The life time of an AVF is a period time from the AVF used for hemodialysis treatment at first time to the last time when the AVF can not be used for hemodialysis therapy,, whichever came first, assessed up to 48 months. Since the AVF will be punctured in every hemodialysis session, the function of AVF were detected during every treatment session (3 times per week).	Equal to or larger than 2 years