Role of Monocytes Adhesion and Vascular Lesions in Vascular Access Success or Failure in Uremic Patients

NCT03231410 | Unknown

• 1 other identifier: WroclawMU
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to identify novel predictors of vascular access success or failure in chronic kidney disease patients. Despite efforts to improve placement of arteriovenous fistula (AVF) the primary failure rates are reported as high as 20-50%, but standard tools like ultrasound cannot inform the clinician sufficiently to accurately predict success or failure. The aim of this study is to perform enhanced assessments of arterial health preoperatively and correlate these measurements with vascular lesions (microscopic tissue changes and monocyte infiltration) and early AVF outcome. Activation of monocytes in uremia condition is responsible for endothelium dysfunction, intimal hyperplasia and atherosclerosis. The investigators expect that stiff arteries caused by monocyte dysfunction refer to the poor distensability and probably longer maturation time.

Conditions

End Stage Renal Disease; Arteriovenous Fistula

Keywords

arteriovenous fistula; maturation; monocyte adhesion; vascular access

Outcome Measures

Primary Outcomes (1)

• Primary patency rate

  Primary patency rate

  Baseline to 12 months after AVF creation

Secondary Outcomes (1)

• Hemodialysis AVF blood flow

  Baseline to 12 months after AVF creation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective study with recruitment of consecutive 30 patients with chronic kidney disease stage 4 or 5, who will be referred for vascular access creation for hemodialysis.

You may qualify if:

• aged \>18 years,
• chronic kidney disease with estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2,
• undergoing AVF creation with venous end-to-arterial side anastomosis in the upper extremity.

You may not qualify if:

• Heart failure of New York Heart Association functional class III or IV,
• Episode of cardio- or cerebrovascular event or receiving intervention therapy within 3 months prior to screening.

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Universitätsklinikum Halle: collaborator

Study Sites (1)

Department of Nephrology and Transplantation Medicine

Wroclaw, 50-556, Poland

RECRUITING

Related Publications (7)

• Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.

  PMID: 17507428 BACKGROUND

• Roy-Chaudhury P, Kelly BS, Melhem M, Zhang J, Li J, Desai P, Munda R, Heffelfinger SC. Vascular access in hemodialysis: issues, management, and emerging concepts. Cardiol Clin. 2005 Aug;23(3):249-73. doi: 10.1016/j.ccl.2005.04.004.

  PMID: 16084276 BACKGROUND

• Trojanowicz B, Ulrich C, Seibert E, Fiedler R, Girndt M. Uremic conditions drive human monocytes to pro-atherogenic differentiation via an angiotensin-dependent mechanism. PLoS One. 2014 Jul 8;9(7):e102137. doi: 10.1371/journal.pone.0102137. eCollection 2014.

  PMID: 25003524 BACKGROUND

• Himmelfarb J. Uremic toxicity, oxidative stress, and hemodialysis as renal replacement therapy. Semin Dial. 2009 Nov-Dec;22(6):636-43. doi: 10.1111/j.1525-139X.2009.00659.x.

  PMID: 20017834 BACKGROUND

• Zickler D, Willy K, Girndt M, Fiedler R, Martus P, Storr M, Schindler R. High cut-off dialysis in chronic haemodialysis patients reduces serum procalcific activity. Nephrol Dial Transplant. 2016 Oct;31(10):1706-12. doi: 10.1093/ndt/gfw293. Epub 2016 Jul 20.

  PMID: 27445317 BACKGROUND

• Stoner L, Sabatier MJ. Use of ultrasound for non-invasive assessment of flow-mediated dilation. J Atheroscler Thromb. 2012;19(5):407-21. doi: 10.5551/jat.11395. Epub 2012 Mar 1.

  PMID: 22659525 BACKGROUND

• Yilmaz MI, Stenvinkel P, Sonmez A, Saglam M, Yaman H, Kilic S, Eyileten T, Caglar K, Oguz Y, Vural A, Cakar M, Altun B, Yenicesu M, Carrero JJ. Vascular health, systemic inflammation and progressive reduction in kidney function; clinical determinants and impact on cardiovascular outcomes. Nephrol Dial Transplant. 2011 Nov;26(11):3537-43. doi: 10.1093/ndt/gfr081. Epub 2011 Mar 4.

  PMID: 21378154 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Transcripts of genes related to calcification (osteopontin, osteokalcin, RunX2), inflammation (TNFa, IL6) and atherosclerosis (ACE/ACE2, VCAM-1, ICAM-1) processes will be assessed.

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Tomasz Gołębiowski, MD, PhD

  Department of Nephrology and Transplantation Medicine, Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Mariusz Kusztal, MD, PhD

  Department of Nephrology and Transplantation Medicine, Wroclaw Medical University

  STUDY DIRECTOR

• Krzysztof Letachowicz, MD, PhD

  Department of Nephrology and Transplantation Medicine, Wroclaw Medical University

  STUDY CHAIR

Central Study Contacts

Tomasz Gołębiowski, MD, PhD

CONTACT

+48 71 7332546; tgolebiowski@op.pl

Mariusz Kusztal, MD, PhD

CONTACT

+48 71 7332500; mariok@o2.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 27, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)