Inflammatory Marker and Pre-existing Venous Fibrosis to Predict AVF Mal-maturation

NCT05136859 | Unknown

• 1 other identifier: 202006195RINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage renal disease patients needs a functional vascular access to receive hemodialysis and prolong their lives. Arteriovenous fistula (AVF) is priority consideration for hemodialysis, which is a connecting a superficial vein to a nearby artery and allowing this vein to enlarge and increase in internal diameter under arterial circulation. Unfortunately, 30-50% of fistulae fail to mature. Vascular calcification and stenosis were considered for early failure. The perivascular fat of artery can be predicted successful AVF maturation. However, Few previous studies have compared AVF maturation between perivascular the fat of cephalic vein or removal during the AVF surgery. This study evaluated whether the effect of AVF inflammation and preexisting vascular fibrosis is associated to perivascular the fat of cephalic vein. Investigators will also verify inflammation by analysis of blood and tissue samples, the association of pre-existing fibrosis, and the clinical correlation with AVF early failure. This study will enroll patients with chronic kidney disease stage 5 and stage 6 who will need maintenance-hemodialysis (HD) from Nov 2021 to Dec 2022. Investigators will use the preoperative ultrasound assessment tool to confirm the feasibility of the arm vessels for the creation of a native AVF. As a prospective randomized controlled trial of perivascular fat preservation or removal during the AVF surgery, a study assistant will help the randomization and explain the informed consent to the patient . The subjects are randomly split into two groups: the experimental group will have the perivascular fat of the target cephalic vein preserved the control group will have the fat removed before the AVF anastomosis. The survey will enroll 100 adult patients and categorize them into groups according to each AVF maturation, JAS, or FTM (see definition below) by 3 - 12 after the surgery.

Conditions

Arteriovenous Fistula

Keywords

hemodialysis; Inflammation; Arteriovenous Fistula; perivascular fat

Outcome Measures

Primary Outcomes (2)

• The success by ultrasound parameters.

  Investigators propose an objective ultrasound scoring system(A hemodialysis arteriovenous fistula maturity score based on the following three objective ultrasonic measurements). Higher scores indicating more mature. Give a summary score range from 0 to 9 points., and of which a total of score 4 or more is considered as HDAVF maturation.

  3 months after surgery

• Definition of delay maturation

  The subject HDAVF is clinically un-feasible for use for HD within 3 months and/or the A hemodialysis arteriovenous fistula maturity score(AFMS) based on the following three objective ultrasonic measurements(0-9) is less than 4. within 3 months and/or the A hemodialysis arteriovenous fistula maturity score based on the following three objective ultrasonic measurements is less than 4(AVF maturity score based on the following three objective ultrasonic measurements. 0 to 9.).

  3 months after surgery

Secondary Outcomes (1)

• The subject HDAVF is clinically un-feasible for use for HD within 3 months and/or the A hemodialysis arteriovenous fistula maturity score(AFMS) based on the following three objective ultrasonic measurements(0-9) is less than 4.

  3 months after surgery

Study Arms (2)

preserve

EXPERIMENTAL

preserve the perivascular fat of the target cephalic vein

Procedure: preserve

remove

NO INTERVENTION

remove from perivascular fat of the target cephalic vein

Interventions

preserve PROCEDURE

preserve the perivascular fat of the target cephalic vein

preserve

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 20 and older adult patients.
• preoperatively clinical and ultrasound assessment of the arm vessels are visible for the creation of a native HDAVF that include：the augmented diameters of the veins is \> 2.0 mm and the diameter of the radial artery is\> 2.0 mm. Besides, there is no obvious stenosis of vessels in the forearm.

You may not qualify if:

• The patient refused to join the study
• serious heart failure (Physicians identify insufficient cardiac output that may affect sacral blood flow development after surgery)
• Unconsciousness
• Bedridden for long time
• systemic lupus erythematosus(SLE), or other known autoimmune diseases
• The physician excludes the possibility of creating a wrist HDAVF before surgery
• Surgeon preoperatively identifies vessel inadequacy for the creation of a wrist HDAVF
• Choose a site other than the wrist for surgery
• Unexpected complications happen during the surgery that prevent the completion of a wrist HDAVF

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (9)

• Martinez L, Duque JC, Tabbara M, Paez A, Selman G, Hernandez DR, Sundberg CA, Tey JCS, Shiu YT, Cheung AK, Allon M, Velazquez OC, Salman LH, Vazquez-Padron RI. Fibrotic Venous Remodeling and Nonmaturation of Arteriovenous Fistulas. J Am Soc Nephrol. 2018 Mar;29(3):1030-1040. doi: 10.1681/ASN.2017050559. Epub 2018 Jan 2.

  PMID: 29295872 RESULT

• Kheda MF, Brenner LE, Patel MJ, Wynn JJ, White JJ, Prisant LM, Jones SA, Paulson WD. Influence of arterial elasticity and vessel dilatation on arteriovenous fistula maturation: a prospective cohort study. Nephrol Dial Transplant. 2010 Feb;25(2):525-31. doi: 10.1093/ndt/gfp462. Epub 2009 Sep 15.

  PMID: 19755475 RESULT

• Holzapfel GA. Collagen in arterial walls: biomechanical aspects. In: Collagen. Springer; 2008:285-324.

  RESULT

• Shiu YT, Litovsky SH, Cheung AK, Pike DB, Tey JCS, Zhang Y, Young CJ, Robbin M, Hoyt K, Allon M. Preoperative Vascular Medial Fibrosis and Arteriovenous Fistula Development. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1615-1623. doi: 10.2215/CJN.00500116. Epub 2016 Aug 30.

  PMID: 27577243 RESULT

• Brahmbhatt A, Remuzzi A, Franzoni M, Misra S. The molecular mechanisms of hemodialysis vascular access failure. Kidney Int. 2016 Feb;89(2):303-316. doi: 10.1016/j.kint.2015.12.019.

  PMID: 26806833 RESULT

• Lee HS, Park MJ, Yoon SY, Joo N, Song YR, Kim HJ, Kim SG, Nizet V, Kim JK. Role of peribrachial fat as a key determinant of brachial artery dilatation for successful arteriovenous fistula maturation in hemodialysis patients. Sci Rep. 2020 Mar 2;10(1):3841. doi: 10.1038/s41598-020-60734-8.

  PMID: 32123226 RESULT

• Bourquelot P, Tawakol JB, Gaudric J, Natario A, Franco G, Turmel-Rodrigues L, Van Laere O, Raynaud A. Lipectomy as a new approach to secondary procedure superficialization of direct autogenous forearm radial-cephalic arteriovenous accesses for hemodialysis. J Vasc Surg. 2009 Aug;50(2):369-74, 374.e1. doi: 10.1016/j.jvs.2009.03.009.

  PMID: 19631871 RESULT

• Lee T, Mokrzycki M, Moist L, Maya I, Vazquez M, Lok CE; North American Vascular Access Consortium. Standardized definitions for hemodialysis vascular access. Semin Dial. 2011 Sep-Oct;24(5):515-24. doi: 10.1111/j.1525-139X.2011.00969.x. Epub 2011 Sep 9.

  PMID: 21906166 RESULT

• Murphy EA, Ross RA, Jones RG, Gandy SJ, Aristokleous N, Salsano M, Weir-McCall JR, Matthew S, Houston JG. Imaging in Vascular Access. Cardiovasc Eng Technol. 2017 Sep;8(3):255-272. doi: 10.1007/s13239-017-0317-y. Epub 2017 Jul 13.

  PMID: 28707187 RESULT

MeSH Terms

Conditions

Arteriovenous Fistula; Inflammation

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Chih-Yang Chan, PhD

CONTACT

+886972651147; chanchihyang@gmail.com

Po-Ya Chang, MsC

CONTACT

+886975810806; poyachang0913@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 29, 2021
• Study Start: December 11, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

TW (1)