A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients

A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.

Study Overview

• Status: Completed
• Conditions: Vascular Fistula
• Intervention / Treatment: Procedure: mNT-BBAVF; Procedure: BCAVF

Detailed Description

The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital/Brown University Medicine School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age from 18 to 75 years;
• Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
• Brachial artery diameter ≥ 2 mm

Exclusion Criteria:

• Stenosis or thrombosis present in the draining vein;
• A history of peripheral ischemia in upper extremities;
• Active local or systemic infections;
• Inability to consent for the procedure;
• Patients with previous dysfunctional forearm fistula.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: mNT-BBAVF; Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access	Procedure: mNT-BBAVF; mNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.
ACTIVE_COMPARATOR: BCAVF; Patients in CKD stage 4-5 without previous dysfunctional fistula access	Procedure: BCAVF; BCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary unassited patency	The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative patency	The interval from the time of access placement to access abandonment, including intervening (all surgical and endovascular interventions) designed to reestablish the functionality of thrombosed access.	12 month
Short-term complications	Complications of both mNT-BBAVF and BCAVF groups within 1 month (thrombosis, failure of maturation, bleeding, steal syndrome, arm edema and severe arm pain)	1 month
Long-term complications	Complications of both mNT-BBAVF and BCAVF groups within 12 months (thrombosis, stenosis and aneurysm).	12 months
Calculated blood flow volumes of the corresponding fistula segments	Blood flow volume (ml/min) = mean velocity (cm/s) * area (r2π) * 60 seconds.	12 months
Diameters of the veins and arteries in the corresponding arm	Vessels's diameters (cm) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.	12 months
Blood flow velocities of the veins and arteries in the corresponding arm.	Blood flow velocities (cm/s) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.	12 months

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: AI Peng, M.D., Ph.D., The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (ESTIMATE): August 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: hemodialysis; vascular access
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Vascular Fistula
• Other Study ID Numbers: Shanghai10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO