Hemodialysis
Conditions
Brief 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.
Interventions
BIOLOGICALBiological analysis
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis
Sponsors
University Grenoble Alps
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation
Intervention model description
Rheopheresis procedure/Shamapheresis procedure
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or more and included in the RHEOPAD protocol (2019-A01513-54) * ESRD treated by hemodialysis or hemodiafiltration * PAD-LTI with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion, subject to the feasibility of the measures: arterial pressure assessment at the ankle \<70 mmHg, or toe pressure 30 mm Hg, or transcutaneous oximetry measurements \< 40 mm Hg * Interventional or surgical revascularization either not technically possible or no necessary * Medical insurance * Signed informed consent
Exclusion criteria
* \- Uncontrolled infection despite well-conducted antibiotic therapy * Life expectancy \< 1 year * Severe cognitive or psychiatric disorders * Pregnant woman, parturient, nursing mother * Patients unable to give an informed consent or unwilling to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood viscosity measured by rotational rheometer | Immediately before 1ST and immediately after 12th procedure , outcome measurement will be reported at the end of the study (approximately 3 years) | To assess the effect of rheopheresis on blood viscosity of chronic hemodialysis patients with PAD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood viscosity measured by rotational rheometer | up to 24 weeks | Evaluate the effect of rheopheresis on blood viscosity measured by rotational rheometer before the 12th treatment session |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of rheopheresis on plasma viscosity measured by falling ball viscometer | Immediately before day 0 and 12-th procedure and immediately after 1st procedure | Plasma viscosity measured by falling ball viscometer in pre vs post session 1 and in pre session 12 vs baseline. |
| Evaluate the effect of rheopheresis on skin microvascular function (1st and 12th sessions pre and post session) | Immediately before day0 and 1 years | Post-occlusive and thermal hyperaemia of cutaneous blood flow measured by speckle contrast imaging, compared between the rheopheresis and shamapheresis groups (1st and 12th sessions pre and post session) |
| Evaluate the effect of rheopheresis on coagulation | Immediately before day 0 and 12-th procedure and immediately after 1st procedure | Study of the lifespan of the blood clot (difference between formation time and clot lysis time) using a multi-well plate spectrophotometer (Fibrinography); |
Countries
France
Contacts
Primary ContactHAMZA MD NACIRI BENNANI
Outcome results
None listed