Actively Recruiting
Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-27
50
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In recent years, expanded hemodialysis has been the subject of studies, many of them done on small populations, with limited observation periods and not always unambiguous results. In the literature, there are data comparing HDx and high-flow hemodialysis in terms of small- and medium-molecule purification and control of inflammation indices; there are fewer data comparing HDx and HDF online. In contrast, there are no studies in the literature comparing HDx with HFR. With a view to personalizing therapy, demonstrating the equivalence/superiority of HDx over the other dialysis techniques under consideration could make this technique suitable precisely for that class of more malnourished and more frail patients who to date do not obtain benefits from the other methods. The objective of the study is the mid-term (12-month) evaluation and comparison of the MCO filter called Theranova 400™ (1.7 m2, steam sterilization, cut-off 25 Kda, Baxter, Heichingen, Germany) with high-flux hemodialysis (HF-HD), OL- HDF and hemodiafiltration with endogenous reinfusion (HFR) with HFR filter 17 , in combination with medical therapy under normal clinical practice, in terms of purification of low and medium molecular weight uremic toxins, control of baseline inflammatory status and erythropoietin resistance in patients with chronic renal failure undergoing hemodialysis treatment.
CONDITIONS
Official Title
Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- On chronic hemodialytic treatment for at least 6 months using MCO filter (Theranova), HF filter, OL-HDF, or HFR with HFR17 filter
- Continuous use of the same filter for at least 12 months
- Diuresis less than 200 ml per day
- Undergoing trisweekly hemodialysis treatment
- Dialysis session duration of at least 210 minutes
- Availability of clinical data collected during follow-up at the O.U. of Nephrology, Dialysis and Transplantation - La Manna
You will not qualify if you...
- Intradialytic hypotension
- Need for dialysis without heparin
- Active bleeding
- Active hematologic diseases
- Thrombocytopenia
- Chronic liver diseases
- Active systemic inflammatory diseases
- Uncontrolled diabetes mellitus
- Temporary vascular access
- Recurrent vascular access infections
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
Research Team
M
Marcello Demetri, Biology
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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