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Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

Primary Purpose

End Stage Renal Disease on Dialysis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

mNT-BBAVF

RCAVF

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
Adult (age ≥ 18 years old);
Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
Estimated life expectancy > 1 year;
Written informed consent obtained;
Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation

Exclusion Criteria:

Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
New York Heart Association class III or IV heart failure;
Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
Prior arm surgically created access in the planned treatment arm;
Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mNT-BBAVF

RCAVF

Arm Description

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

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

Outcomes

Primary Outcome Measures

Primary Unassisted Patency

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

Secondary Outcome Measures

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

Cumulative Patency

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

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.

Full Information

NCT ID

NCT03701243

First Posted

October 7, 2018

Last Updated

September 23, 2019

Sponsor

Shanghai 10th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03701243

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

October 31, 2020 (Anticipated)

Study Completion Date

October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease on Dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mNT-BBAVF

Arm Type

Experimental

Arm Description

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

Arm Title

RCAVF

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

mNT-BBAVF

Intervention Description

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

Intervention Name(s)

RCAVF

Intervention Description

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.

Primary Outcome Measure Information:

Title

Primary Unassisted Patency

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Immediate Vascular Access Failure

Description

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

Time Frame

72 hours

Title

Cumulative Patency

Description

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

Time Frame

1 year

Title

Early Dialysis Suitability Failure

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula; Adult (age ≥ 18 years old); Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm; Estimated life expectancy > 1 year; Written informed consent obtained; Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation Exclusion Criteria: Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study; New York Heart Association class III or IV heart failure; Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study; Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation; Prior arm surgically created access in the planned treatment arm; Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changbin Li, MD

Phone

+86 13916907936

changbin_li@tongji.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Dayong Hu, MD

Phone

+86 13585988609

hdy455@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ai Peng, MD, PhD

Organizational Affiliation

Shanghai 10th People's Hospital of Tongji University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200072

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changin Li, MD

changbin_li@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27296523

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.

Results Reference

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Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

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