A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

NCT ID: NCT02519933

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-08-31

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.

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).

Conditions

Vascular Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mNT-BBAVF

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

Group Type: ACTIVE_COMPARATOR

mNT-BBAVF

Intervention Type: 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.

BCAVF

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

Group Type: ACTIVE_COMPARATOR

BCAVF

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ai Peng

Director of the department of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AI Peng, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Rhode Island Hospital/Brown University Medicine School

Providence, Rhode Island, United States

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

Shanghai, Shanghai Municipality, China

Countries

United States; China

Other Identifiers

Shanghai10

Identifier Type: -

Identifier Source: org_study_id