Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

A Multicenter, Open-labelled, Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03701243
• Other study ID #: mNT-BBAVF vs RCAVF
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2019
• Source: Shanghai 10th People's Hospital
• Contact: Changbin Li, MD
• Phone: +86 13916907936
• Email: changbin_li[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.

Description:

Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;

2. Adult (age = 18 years old);

3. Preoperative Doppler ultrasonography showing target vein diameter(s) = 2.0 mm and target artery diameter(s) = 2.0 mm;

4. Estimated life expectancy > 1 year;

5. Written informed consent obtained;

6. Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation

Exclusion Criteria:

1. Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;

2. New York Heart Association class III or IV heart failure;

3. Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;

4. Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;

5. Prior arm surgically created access in the planned treatment arm;

6. Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Procedure:
• mNT-BBAVF
Briefly, to construct an mNT-BBAVF, an incision is made on the ulnar side of the elbow. The brachial artery and basilic vein are then isolated, and a side-to-side anastomosis is performed without transposition of the basilic vein.
• RCAVF
Briefly, to construct a wrist RCAVF, an incision is made on the radial side of the wrist. The radial artery and cephalic vein are then isolated, and a end-to-side anastomosis is performed.

Locations

Country	Name	City	State
China	Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Hu D, Li C, Sun L, Zhou C, Li X, Ai Z, Tang J, Peng A. A modified nontransposed brachiobasilic arteriovenous fistula versus brachiocephalic arteriovenous fistula for maintenance hemodialysis access. J Vasc Surg. 2016 Oct;64(4):1059-65. doi: 10.1016/j.jvs.2016.03.450. Epub 2016 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Unassisted Patency	This is the time of access creation or placement until any first intervention to maintain or restore blood flow	1 year
Secondary	Immediate Vascular Access Failure	This is an access that has either no appearance of or a loss of bruit or thrill within 72 hours of creation	72 hours
Secondary	Cumulative Patency	This is the time of access creation or placement until access abandonment	1 year
Secondary	Early Dialysis Suitability Failure	This is an access that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the third month following its creation.	3 months