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

NCT02880761 | Completed Results

• 1 other identifier: 2016-019
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arteriovenous Fistulae

Keywords

hemodialysis; chronic renal failure; arteriovenous fistulae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Life Time of AVF

  Equal to or larger than 2 years

Other Outcomes (1)

• Mean Value of Urea Clearance Index During 24 Months

  2 years

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Procedure: Assessment guiding surgery and puncture for AVF

Control

NO INTERVENTION

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.

Interventions

Assessment guiding surgery and puncture for AVF PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maintenance hemodialysis patients using AVF;
• Ages 18-70 years old;
• Agreement with frequent following-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead
• Peking University International Hospital: collaborator

Study Sites (1)

Peking University International Hospital

Beijing, Beijing Municipality, 102206, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Punctures

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Director of Continuous Quality Improvement Experts Congress of Changping District
• Organization: Continuous Quality Improvement Experts Congress of Changping District

zhangdongliang@pkuih.edu.cn

+861069006549

Study Officials

• Dongliang Zhang, Doctor

  Peking University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated director of blood purification center

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 26, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-06

Locations

CN (1)