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

End Stage Renal Disease Clinical Trial

— IVUS in ESRD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399941
• Other study ID #: H-37396
• Secondary ID: 1R21DK119740-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Boston Medical Center
• Contact: Vipul Chitalia, MD PhD
• Phone: 617 638 7330
• Email: vipul.chitalia[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Diagnostic Test:
• Venography
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.
• Intravascular 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.

Other:
• Image 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

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Morphology of lesion	The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.	18 months