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

Capital Medical University

Status: Completed

Conditions: Arteriovenous Fistulae

Treatments: Procedure: Assessment guiding surgery and puncture for AVF

Study type: Interventional

Funder types: Other

Identifiers

NCT02880761

2016-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.

Treatment:

Procedure: Assessment guiding surgery and puncture for AVF

Control

No Intervention group

Description:

Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.