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Relationship Between Arterial Variations and Patency of Arteriovenous Fistulae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613115
Recruitment Status : Active, not recruiting
First Posted : November 3, 2020
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Beijing Tongren Hospital

Study Description
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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
Arteriovenous Fistula Ultrasound Artery

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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 : July 1, 2020
Actual Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. the variations in the branching pattern of the main arteries in the upper limb of Chinese. [ Time Frame: 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 [ Time Frame: 1 year ]
    functional patency、primary patency、primary assisted patency、secondary patency


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all patients who were admitted to the vascular surgical Inpatient department from outpatient department.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613115


Locations
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China, Beijing
Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University
BeiJing, Beijing, China, 100730
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
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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.
More Information
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Publications:

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Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT04613115    
Other Study ID Numbers: TRECKY2020-101
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities