Actively Recruiting
Comparison of Expanded Hemodialysis With Other Dialysis Techniques in Removing 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating different dialysis methods for patients with chronic end-stage renal disease to compare how well they remove small- and medium-sized uremic toxins, control inflammation, and affect erythropoietin resistance. The study focuses on four dialysis techniques: expanded hemodialysis (HDx) using the Theranova 400TM filter, high-flux hemodialysis (HF-HD), online hemodiafiltration (OL-HDF), and hemodiafiltration with endogenous reinfusion (HFR). This observational study aims to personalize dialysis treatment by evaluating these methods over a mid-term period of 12 months. The study analyzes data from about 50 patients divided into four groups based on the dialysis method used, with each group having at least 10 patients treated at a specialized nephrology center from 2018 to 2022. Patients have been receiving their respective dialysis treatments as part of regular clinical care, including tri-weekly sessions lasting at least 210 minutes. No study-specific treatments or visits are added beyond standard clinical practice. Participants' clinical data collected during their routine care will be reviewed and analyzed over 18 months after ethics approval. Data include blood parameters and clinical events documented in patients' medical records, which will be securely managed and pseudonymized. The study will measure differences in dialysis methods at baseline, 3 months, and 12 months to assess their performance and impact on patients' health.
CONDITIONS
Brief 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 hemodialysis treatment for at least 6 months using MCO filter (Theranova), high-flux filter, OL-HDF, or HFR with HFR17 filter
- Continuous use of the same dialysis filter for at least 12 months
- Urine output less than 200 ml per day
- Receiving hemodialysis treatment three times a week
- Each dialysis session lasts at least 210 minutes
- Availability of clinical data from follow-up at the Nephrology, Dialysis and Transplantation Unit
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 infections of vascular access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 12 months
Participants who undergo routine hemodialysis treatment are observed and clinical data are collected from their medical records over time.
Data collected at baseline, 3 months, and 12 months
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
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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