Rheopheresis Mechanism in Hemodialysis Patients With PAD
NCT ID: NCT05373524
Last Updated: 2022-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2022-06-30
2024-05-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the rheopheresis group
Rheopheresis is performed using an automated monitor in a double-filtration cascade. Plasma purify from of high molecular weight proteins through a secondary filter is then returned to the patient. This technique is performed in tandem with a hemodialysis monitor.
Biological analysis
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis
the shamapheresis group
Shamapheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. This technique is performed in tandem with a hemodialysis monitor.
Biological analysis
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis
Interventions
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Biological analysis
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Grenoble Alps
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Grenoble University Hospital
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Roustit M, Cracowski JL. Assessment of endothelial and neurovascular function in human skin microcirculation. Trends Pharmacol Sci. 2013 Jul;34(7):373-84. doi: 10.1016/j.tips.2013.05.007. Epub 2013 Jun 21.
Meyer A, Fiessler C, Stavroulakis K, Torsello G, Bisdas T, Lang W; CRITISCH collaborators. Outcomes of dialysis patients with critical limb ischemia after revascularization compared with patients with normal renal function. J Vasc Surg. 2018 Sep;68(3):822-829.e1. doi: 10.1016/j.jvs.2017.12.048. Epub 2018 Mar 26.
Lowry D, Saeed M, Narendran P, Tiwari A. The Difference Between the Healing and the Nonhealing Diabetic Foot Ulcer: A Review of the Role of the Microcirculation. J Diabetes Sci Technol. 2017 Sep;11(5):914-923. doi: 10.1177/1932296816658054. Epub 2016 Jul 10.
Weiss N. A critical review on the use of lipid apheresis and rheopheresis for treatment of peripheral arterial disease and the diabetic foot syndrome. Semin Dial. 2012 Mar-Apr;25(2):220-7. doi: 10.1111/j.1525-139X.2011.01036.x. Epub 2011 Dec 16.
Ferrannini M, Vischini G, Staffolani E, Scaccia F, Miani N, Parravano MC, Louis MM, Splendiani G, Di Daniele N. Rheopheresis in vascular diseases. Int J Artif Organs. 2007 Oct;30(10):923-9. doi: 10.1177/039139880703001010.
Klingel R, Mumme C, Fassbender T, Himmelsbach F, Altes U, Lotz J, Pohlmann T, Beyer J, Kustner E. Rheopheresis in patients with ischemic diabetic foot syndrome: results of an open label prospective pilot trial. Ther Apher Dial. 2003 Aug;7(4):444-55. doi: 10.1046/j.1526-0968.2003.00082.x.
Kirschkamp T, Schmid-Schonbein H, Weinberger A, Smeets R. Effects of fibrinogen and alpha2-macroglobulin and their apheretic elimination on general blood rheology and rheological characteristics of red blood cell aggregates. Ther Apher Dial. 2008 Oct;12(5):360-7. doi: 10.1111/j.1744-9987.2008.00610.x.
Briers JD. Laser Doppler, speckle and related techniques for blood perfusion mapping and imaging. Physiol Meas. 2001 Nov;22(4):R35-66. doi: 10.1088/0967-3334/22/4/201.
Roustit M, Millet C, Blaise S, Dufournet B, Cracowski JL. Excellent reproducibility of laser speckle contrast imaging to assess skin microvascular reactivity. Microvasc Res. 2010 Dec;80(3):505-11. doi: 10.1016/j.mvr.2010.05.012. Epub 2010 Jun 9.
Choi B, Ramirez-San-Juan JC, Lotfi J, Stuart Nelson J. Linear response range characterization and in vivo application of laser speckle imaging of blood flow dynamics. J Biomed Opt. 2006 Jul-Aug;11(4):041129. doi: 10.1117/1.2341196.
Stewart CJ, Frank R, Forrester KR, Tulip J, Lindsay R, Bray RC. A comparison of two laser-based methods for determination of burn scar perfusion: laser Doppler versus laser speckle imaging. Burns. 2005 Sep;31(6):744-52. doi: 10.1016/j.burns.2005.04.004.
Other Identifiers
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38RC20.461
Identifier Type: -
Identifier Source: org_study_id
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