Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis (IVUS in ESRD)

Boston Medical Center (BMC)

Status: Enrolling

Conditions: End Stage Renal Disease

Treatments: Diagnostic Test: Venography; Diagnostic Test: Intravascular ultrasound (IVUS); Other: Image processing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04399941

1R21DK119740-01A1 (U.S. NIH Grant/Contract)

H-37396

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

IVUS and venography group

Experimental group

Description:

Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.

Treatment:

Other: Image processing

Diagnostic Test: Intravascular ultrasound (IVUS)

Diagnostic Test: Venography