Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis

Study Overview
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Brief Summary
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Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.

Official Title
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Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Diagnostic Test: Venography
* Diagnostic Test: Intravascular ultrasound (IVUS)
* Other: Image processing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ESRD (end stage renal disease) patients at BMC (Boston Medical Center) Receiving hemodialysis Has a dialysis access malfunction Undergoing a diagnostic fistulogram for the dialysis access malfunction Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS and venography group<br>Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing. | Diagnostic Test: Venography<br>* The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.<br>* Other names: Fistulogram;Diagnostic Test: Intravascular ultrasound (IVUS)<br>* IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.<br>Other: Image processing<br>* Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of stenosis | The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA. | 18 months | 
| Length of lesions | The length of each lesion will be measured between points with >50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment. | 18 months | 
| Morphology of lesion | The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous ultrasound (IVUS), central venous stenosis (CVS), hemodialysis, dialysis access malfunction, fistulogram, stenosis, virtual histology (VH-IVUS) software