Health TrialsbyHealthPanel

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

ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBoston Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Venography

    Diagnostic test

    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)

    Diagnostic test

    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.

  • Image processing

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: IVUS and venography groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months
2

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.

Time frame
18 months
3

Morphology of lesion

The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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