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Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03701243
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: mNT-BBAVF
  • Procedure: RCAVF
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: mNT-BBAVF

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

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.
Active Comparator: RCAVF

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

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.

Outcome Measures

Primary Outcome Measures

  1. Primary Unassisted Patency [1 year]

    This is the time of access creation or placement until any first intervention to maintain or restore blood flow

Secondary Outcome Measures

  1. Immediate Vascular Access Failure [72 hours]

    This is an access that has either no appearance of or a loss of bruit or thrill within 72 hours of creation

  2. Cumulative Patency [1 year]

    This is the time of access creation or placement until access abandonment

  3. Early Dialysis Suitability Failure [3 months]

    This is an access that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the third month following its creation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Ai Peng, MD, PhD, Shanghai 10th People's Hospital of Tongji University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ai Peng, MD, PhD, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT03701243
Other Study ID Numbers:
  • mNT-BBAVF vs RCAVF
First Posted:
Oct 9, 2018
Last Update Posted:
Sep 25, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of Sep 25, 2019