Actively Recruiting
Retrospective Analysis of Performance and Treatment Data for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Acute and Chronic Haemodialysis Patients
Led by Fresenius Medical Care Deutschland GmbH · Updated on 2025-06-22
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fresenius Medical Care Deutschland GmbH
Lead Sponsor
A
Alcedis GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are analyzing past performance and treatment data for three investigational devices: the Genius SleddFlux Filter, Ultraflux AV 600 S Filter, and Genius 90 Concentrates. This study focuses on patients with renal failure, including those undergoing acute haemodialysis (aHD) who are haemodynamically unstable, as well as chronic haemodialysis (cHD) patients. The purpose is to understand how these devices perform during haemodialysis and to assess any improvements in kidney function for acute patients. Data from patients treated between January and December 2019 with these devices will be reviewed retrospectively. The study looks at two groups: acute haemodialysis patients and chronic haemodialysis patients. For acute patients, at least three of the five primary variables—daily urea, creatinine, potassium, ultrafiltration volume, and effluent volume—must be available for half of their treatments. For chronic patients, ultrafiltration values must be available for all treatments, along with weekly urea and creatinine measurements. Participants' daily lab values such as urea, creatinine, and potassium will be collected along with treatment-specific data like ultrafiltration and effluent volumes. These measurements are taken during haemodialysis treatment as part of routine clinical practice. The research team will analyze these data points to evaluate the device characteristics and treatment outcomes. The study is observational and retrospective, with no new treatments administered, and the data collection period covers treatments from 2019.
CONDITIONS
Brief Title
Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with kidney failure who received extracorporeal blood treatment using the investigational devices between January 2019 and December 2019
- For acute haemodialysis patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration volume, effluent volume) for 50% of treatments
- For chronic haemodialysis patients: availability of ultrafiltration values for all treatments and at least one urea and creatinine value per week
You will not qualify if you...
- Use of another filter or adsorber simultaneously for a different therapy
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.
Duration - Data collected for treatments between January 2019 and December 2019
Participants who underwent haemodialysis using the specified filters are observed through retrospective data analysis of treatment parameters.
Trial Site Locations
Total: 2 locations
1
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
2
Universitätsklinikum Jena
Jena, Germany, 07743
Actively Recruiting
Research Team
T
Tatiana De los Rios
J
Jana Schmitt
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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