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Rheopheresis Mechanism in Hemodialysis Patients With PAD

NCT05373524 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-05-13

No results posted yet for this study

Summary

Peripheral arterial disease (PAD) is common in chronic hemodialysis patients (HDC) with a prevalence of 30% according to the DOPPS study.

The combination of PAD and chronic kidney disease (CKD) stage 5 is a risk factor for major amputation (24.5%) with a mortality rate of 55% at 2 years.

Ischemia occurring during PAD is the result of impaired microcirculation, with insufficient blood flow to maintain tissue perfusion and viability.

It is responsible for painful skin wounds whose healing is poor, with a significant risk of infection.

In patients with chronic renal failure, it is linked to both:

* local phenomena (atherosclerosis, calcification)
* changes in blood viscosity (elevated hematocrit and inflammatory proteins, especially fibrinogen)
* a neovascularization defect (uremic toxins, in particular indoxyl sulphate). If revascularization is not possible, amputation remains the only possible treatment to relieve pain and limit the risk of infection.

Rheopheresis is an apheresis technique that allows the depletion of high molecular weight serum proteins.

This would reduce blood viscosity and red blood cell (RBC) aggregation, thereby improving microvascular perfusion, with the aim of reducing pain, improving healing and limiting the risk of amputation.

Several studies have investigated the efficacy of rheopheresis in PAD in HDC, but the level of evidence remains low.

Conditions

  • Hemodialysis

Interventions

BIOLOGICAL

Biological analysis

Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis

Sponsors & Collaborators

  • University Grenoble Alps

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373524 on ClinicalTrials.gov