Rheopheresis Mechanism in Hemodialysis Patients With PAD

NCT05373524 | Unknown

• 1 other identifier: 38RC20.461
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change in Blood viscosity measured by rotational rheometer

  To assess the effect of rheopheresis on blood viscosity of chronic hemodialysis patients with PAD

  Immediately before 1ST and immediately after 12th procedure , outcome measurement will be reported at the end of the study (approximately 3 years)

Secondary Outcomes (1)

• Blood viscosity measured by rotational rheometer

  up to 24 weeks

Other Outcomes (3)

• 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

• Evaluate the effect of rheopheresis on skin microvascular function (1st and 12th sessions pre and post session)

  Immediately before day0 and 1 years

• Evaluate the effect of rheopheresis on coagulation

  Immediately before day 0 and 12-th procedure and immediately after 1st procedure

Study Arms (2)

the rheopheresis group

ACTIVE COMPARATOR

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: Biological analysis

the shamapheresis group

PLACEBO COMPARATOR

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: Biological analysis

Interventions

Biological analysis BIOLOGICAL

Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis

the rheopheresis group; the shamapheresis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

Related Publications (11)

• 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.

  PMID: 23791036 BACKGROUND

• 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.

  PMID: 29598891 RESULT

• 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.

  PMID: 27390224 RESULT

• 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.

  PMID: 22175277 RESULT

• 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.

  PMID: 17992654 RESULT

• 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.

  PMID: 12887730 RESULT

• 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.

  PMID: 18937718 RESULT

• 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.

  PMID: 11761081 RESULT

• 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.

  PMID: 20542492 RESULT

• 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.

  PMID: 16965157 RESULT

• 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.

  PMID: 16129229 RESULT

MeSH Terms

Interventions

Biological Oxygen Demand Analysis

Intervention Hierarchy (Ancestors)

Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

HAMZA MD NACIRI BENNANI

CONTACT

33476765460; HNaciribennani@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Rheopheresis procedure/Shamapheresis procedure

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: May 13, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)