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

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease
• Interventions: Diagnostic Test: Venography; Diagnostic Test: Intravascular ultrasound (IVUS); Other: Image processing

• Registration Number: NCT04399941
• Lead Sponsor: Boston Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-22
• Study Start: 2021-08-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IVUS and venography group	Intravascular ultrasound (IVUS)	Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
IVUS and venography group	Image processing	Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
IVUS and venography group	Venography	Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.

Primary Outcome Measures

Name	Time	Method
Morphology of lesion	18 months	The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
Extent of stenosis	18 months	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.
Length of lesions	18 months	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.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States