Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

Tongji University

Status: Unknown

Conditions: End Stage Renal Disease on Dialysis

Treatments: Procedure: mNT-BBAVF; Procedure: RCAVF

Study type: Interventional

Funder types: Other

Identifiers

NCT03701243

mNT-BBAVF vs RCAVF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

mNT-BBAVF

Experimental group

Description:

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

Treatment:

Procedure: mNT-BBAVF

RCAVF

Active Comparator group

Description:

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

Treatment:

Procedure: RCAVF