NCT05373524

Rheopheresis Mechanism in Hemodialysis Patients With PAD

Rheopheresis Mechanism of Action and Impacts on the Evolution of Peripheral Arterial Disease in Hemodialysis Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main objective of our study is to evaluate the impact of rheopheresis on blood (main objective) and plasma viscosity, skin microcirculation and blood coagulation (Fibrinography, Thrombin Generation). No study has evaluated the direct effect of rheopheresis on these different parameters. However, a better understanding of these mechanisms would make it possible both to optimize the effectiveness of the technique, to limit its potential side effects and the cost of treatment.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
BIOLOGICAL	Biological analysis	Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-05-13
• Last updated: 2022-05-13

Locations

1 site across 1 country: France