Status:
UNKNOWN
Rheopheresis Mechanism in Hemodialysis Patients With PAD
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
University Grenoble Alps
Conditions:
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 Generatio...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05373524
Start Date
June 1 2022
End Date
May 1 2024
Last Update
May 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Grenoble University Hospital
Grenoble, France, 38043