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A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT02519933
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ai Peng, Shanghai 10th People's Hospital

Brief Summary:
A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.

Condition or disease Intervention/treatment Phase
Vascular Fistula Procedure: mNT-BBAVF Procedure: BCAVF Not Applicable

Detailed Description:
The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
Study Start Date : April 2016
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
Active Comparator: mNT-BBAVF
Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access
Procedure: mNT-BBAVF
mNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.

Active Comparator: BCAVF
Patients in CKD stage 4-5 without previous dysfunctional fistula access
Procedure: BCAVF
BCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.




Primary Outcome Measures :
  1. Primary unassited patency [ Time Frame: 12 months ]
    The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.


Secondary Outcome Measures :
  1. Cumulative patency [ Time Frame: 12 month ]
    The interval from the time of access placement to access abandonment, including intervening (all surgical and endovascular interventions) designed to reestablish the functionality of thrombosed access.

  2. Short-term complications [ Time Frame: 1 month ]
    Complications of both mNT-BBAVF and BCAVF groups within 1 month (thrombosis, failure of maturation, bleeding, steal syndrome, arm edema and severe arm pain)

  3. Long-term complications [ Time Frame: 12 months ]
    Complications of both mNT-BBAVF and BCAVF groups within 12 months (thrombosis, stenosis and aneurysm).

  4. Calculated blood flow volumes of the corresponding fistula segments [ Time Frame: 12 months ]
    Blood flow volume (ml/min) = mean velocity (cm/s) * area (r2π) * 60 seconds.

  5. Diameters of the veins and arteries in the corresponding arm [ Time Frame: 12 months ]
    Vessels's diameters (cm) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.

  6. Blood flow velocities of the veins and arteries in the corresponding arm. [ Time Frame: 12 months ]
    Blood flow velocities (cm/s) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 to 75 years;
  • Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
  • Brachial artery diameter ≥ 2 mm

Exclusion Criteria:

  • Stenosis or thrombosis present in the draining vein;
  • A history of peripheral ischemia in upper extremities;
  • Active local or systemic infections;
  • Inability to consent for the procedure;
  • Patients with previous dysfunctional forearm fistula.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519933


Locations
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United States, Rhode Island
Rhode Island Hospital/Brown University Medicine School
Providence, Rhode Island, United States, 02903
China, Shanghai
The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: AI Peng, M.D., Ph.D. The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
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Responsible Party: Ai Peng, Director of the department of Nephrology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT02519933    
Other Study ID Numbers: Shanghai10
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ai Peng, Shanghai 10th People's Hospital:
hemodialysis
vascular access
Additional relevant MeSH terms:
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Vascular Fistula
Fistula
Pathological Conditions, Anatomical
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases