A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

NCT02519933 | Completed DMC

• 1 other identifier: Shanghai10
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Vascular Fistula

Keywords

hemodialysis; vascular access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cumulative patency

  12 month

• Short-term complications

  1 month

• Long-term complications

  12 months

• Calculated blood flow volumes of the corresponding fistula segments

  12 months

• Diameters of the veins and arteries in the corresponding arm

  12 months

Study Arms (2)

mNT-BBAVF

ACTIVE COMPARATOR

Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access

Procedure: mNT-BBAVF

BCAVF

ACTIVE COMPARATOR

Patients in CKD stage 4-5 without previous dysfunctional fistula access

Procedure: BCAVF

Interventions

mNT-BBAVF PROCEDURE

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.

mNT-BBAVF

BCAVF PROCEDURE

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.

BCAVF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (2)

Rhode Island Hospital/Brown University Medicine School

Providence, Rhode Island, 02903, United States

Location

The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Vascular Fistula

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• AI Peng, M.D., Ph.D.

  The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Nephrology

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: August 11, 2015
• Study Start: April 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (1)