RecruitingNot ApplicableNCT04399941

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

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


Sponsor

Boston Medical Center

Enrollment

50 participants

Start Date

Aug 3, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study uses a small imaging tool called intravascular ultrasound (IVUS) — a tiny camera on a thin wire — to look inside the blood vessels of patients on dialysis who are experiencing problems with their dialysis access. Dialysis access is the connection (usually a fistula or graft) used to link your blood to the dialysis machine. When it malfunctions, doctors need to investigate why, and this study uses IVUS during that investigation to gather more detailed images than standard methods provide. **You may be eligible if...** - You have end-stage kidney disease (your kidneys no longer work on their own) - You are receiving hemodialysis at Boston Medical Center - Your dialysis access has stopped working properly - You are already scheduled for a diagnostic imaging procedure (fistulogram) to check on your access **You may NOT be eligible if...** - There are no listed exclusion criteria for this study — all patients meeting the above criteria are potentially eligible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTVenography

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.

DIAGNOSTIC_TESTIntravascular ultrasound (IVUS)

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.

OTHERImage processing

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.


Locations(1)

Boston Medical Center

Boston, Massachusetts, United States

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NCT04399941


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