Relationship Between Arterial Variations and Patency of Arteriovenous Fistulae

NCT04613115 | Completed

• 1 other identifier: TRECKY2020-101
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

In 2019, KDOQI considered that uremic patients with a life expectancy of more than one year should require hemodialysis as an effective renal replacement therapy before preparation of kidney transplantation. Arteriovenous fistula, as the lifeline of uremic patients, plays an important role in their daily hemodialysis. The patency of arteriovenous fistula is largely restricted by the inflow artery. According to available medical literatures, an incidence rate of variations in the branching pattern of the main arteries in the upper limb is ranged from 7.2% to 25.0%. and there is a large difference in the incidence rate between sex and race, furthermore, the incidence rate of variations in the branching pattern of the main arteries in the upper limb of Chinese is still unclear. The brachial artery is the main artery of the upper limb. It gives off two terminal branches at the distal end of the elbow crease, the radial and ulnar arteries, the former one often serves as an arterial inflow to create an arteriovenous fistula in the forearm. High bifurcation of the brachial artery (HBBA) seems to be a common variation which may result in immaturity or disfunction of arteriovenous fistulas. Therefore, the purpose of this study is to investigate the variations in the branching pattern of the main arteries in the upper limb of Chinese, in order to study on the hemodynamic changes, and their influence on the establishment, maturation and failure of arteriovenous fistulas in the upper limb.

Conditions

Arteriovenous Fistula; Ultrasound; Artery

Outcome Measures

Primary Outcomes (2)

• the variations in the branching pattern of the main arteries in the upper limb of Chinese.

  brachio-radial artery、superficial brachio-radial artery、brachio-ulnar artery、superficial brachio-ulnar artery、brachioulnoradial artery、brachiointerosseous artery.

  baseline

• Patency of arteriovenous fistulae in the upper limb

  functional patency、primary patency、primary assisted patency、secondary patency

  1 year

Study Arms (4)

Group A

patients without uremia and variant arteries

Group B

patients without uremia, but with variant arteries

Group C

patients with uremia ,without variant arteries

Group D

patients with uremia and variant arteries

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients who were admitted to the vascular surgical Inpatient department from outpatient department.

You may qualify if:

• patients of vascular surgical Inpatient department
• patients will sign the "Informed Consent" and be able to receive related ultrasound examinations

You may not qualify if:

• Patients of other surgical Inpatient department

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• ZhengYa Yu, MD

  Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.

  STUDY DIRECTOR

• Xin Chen, MM

  Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: September 21, 2023

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)