Clinical trial NCT03701243: Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Primary Unassisted Patency
timeFrame: 1 year
Secondary outcomes:
measure: Immediate Vascular Access Failure
timeFrame: 72 hours
measure: Cumulative Patency
timeFrame: 1 year
measure: Early Dialysis Suitability Failure
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital of Tongji University
name: Ai Peng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.