End Stage Renal Disease
Conditions
Keywords
intravenous ultrasound (IVUS), central venous stenosis (CVS), hemodialysis, dialysis access malfunction, fistulogram, stenosis, virtual histology (VH-IVUS) software
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.
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Morphology of lesion | 18 months | The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images. |
Countries
United States
Contacts
Primary ContactVipul Chitalia, MD PhD
Outcome results
None listed