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Optimal Screening Program in Detecting Stenosis and Predicting Thrombosis in Hemodialysis Graft

NCT03839264 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2019-02-15

No results posted yet for this study

Summary

A well-functioning vascular access is essential for providing adequate life-sustaining treatment in patients with end stage renal disease on maintenance hemodialysis. The preferred long-term vascular access is the arteriovenous fistula (AVF), which is created using the vessels of the patient by surgically connecting an artery with a superficial vein to increase the blood flow (Qa) in the venous system, which will dilate allowing the insertion of two needles, one to carry the blood to the dialyzer, and the other to return the cleansed blood to the body with the aid of a dialysis machine. Unfortunately, the high prevalence of vascular disease of the hemodialysis patients make difficult to create an adequate AVF in as many as 20 to 60% of the patients.In these persons, a valid alternative is the arteriovenous graft: in graft method an artery is surgically connected to a vein with a short piece of synthetic soft tube which is implanted under the skin. Needles are inserted in the graft during the dialysis treatment. Compared to an AV, however, graft is at higher risk of complications. The most frequent complication is thrombosis (i.e. the formation of blood clot inside the graft). Usually, thrombosis is the consequence of an underlying significant stenosis (i.e. a greater than 50% narrowing of the vessel or graft lumen by comparison with the lumen of a normal adjacent vessel or graft) and its hemodynamic consequences of decreasing the access blood flow (Qa) and/or increasing pressure within the graft. Therefore, all vascular access guidelines recommend regular noninvasive screening programs of grafts for timely identification of a stenosis associated with some type of functional or hemodynamic impairment, because its repair may prevent thrombosis and lengthen the useful life of the access. Screening methods include clinical monitoring and surveillance, which uses special equipment either to assess the hemodynamic consequences of stenosis by measuring Qa and static venous intra-access pressure ratio (VAPR) or to visualize the stenosis by means of duplex ultrasound (DU). Guidelines also state that there is insufficient evidence to prefer one method to another due to the lack of adequate comparative studies. The purpose of our study is to identify an optimal screening program for stenosis detection and elective repair by comparing the diagnostic performance for stenosis and incipient thrombosis of all the available screening tools in the same graft population

Conditions

  • Arteriovenous Graft Stenosis
  • Arteriovenous Graft Thrombosis

Interventions

DIAGNOSTIC_TEST

Graft stenosis and thrombosis

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Nicola Tessitore, MD · AO Verona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-01
Primary Completion
2018-05-30
Completion
2018-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03839264 on ClinicalTrials.gov