Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

NCT ID: NCT03701243

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-10-31

Brief 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.

Detailed 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.

Conditions

End Stage Renal Disease on Dialysis

Study Design

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

Study Groups

mNT-BBAVF

These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess.

Group Type: EXPERIMENTAL

mNT-BBAVF

Intervention Type: PROCEDURE

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

These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess.

Group Type: ACTIVE_COMPARATOR

RCAVF

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

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

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ai Peng

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ai Peng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital of Tongji University

Locations

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Changbin Li, MD

Role: CONTACT

changbin_li@tongji.edu.cn

+86 13916907936

Dayong Hu, MD

Role: CONTACT

hdy455@hotmail.com

+86 13585988609

Facility Contacts

Changin Li, MD

Role: primary

changbin_li@tongji.edu.cn

References

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.

Reference Type: BACKGROUND

PMID: 27296523 (View on PubMed)

Other Identifiers

mNT-BBAVF vs RCAVF

Identifier Type: -

Identifier Source: org_study_id