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Relationship Between Arterial Variations and Patency of Arteriovenous Fistulae

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04613115
Collaborator
(none)
1,000
Enrollment
1
Location
23
Anticipated Duration (Months)
43.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective analysis research, collecting information after patients admission, including basic information, primary disease status, dialysis intubation status, current dialysis access status, last dialysis access maintenance status and other relevant data. The above-mentioned information data is collected when the patient is admitted into the department of vascular surgery, and is recorded in the "Information Collection, Diagnosis and Treatment Process of Hemodialysis Patients in the Department of Vascular Surgery" form for retention and filing.

    During the study period, all patients who were admitted to the vascular surgical department and signed the "Informed Consent" before the upper extremity artery screening according to the corresponding procedures.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Study on the Relationship Between Variations in the Branching Pattern of the Main Arteries and Patency of Arteriovenous Fistulae in the Upper Limb
    Actual Study Start Date :
    Jul 1, 2020
    Actual Primary Completion Date :
    Jun 30, 2021
    Anticipated Study Completion Date :
    Jun 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. the variations in the branching pattern of the main arteries in the upper limb of Chinese. [baseline]

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

    2. Patency of arteriovenous fistulae in the upper limb [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patients of vascular surgical Inpatient department

    • patients will sign the "Informed Consent" and be able to receive related ultrasound examinations

    Exclusion Criteria:
    • Patients of other surgical Inpatient department

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University BeiJing Beijing China 100730

    Sponsors and Collaborators

    • Beijing Tongren Hospital

    Investigators

    • Study Director: ZhengYa Yu, MD, Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.
    • Principal Investigator: XIn Chen, MM, Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Beijing Tongren Hospital
    ClinicalTrials.gov Identifier:
    NCT04613115
    Other Study ID Numbers:
    • TRECKY2020-101
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Jul 26, 2021
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arteriovenous Fistula
    Fistula

    Study Results

    No Results Posted as of Jul 26, 2021