Status:
RECRUITING
Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
Alcedis GmbH
Conditions:
Renal Failure
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Brief Summary
Retrospective analysis of performance and treatment data collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter \& Genius 90 Concentrates in acute haemodialysis, haemodynamically instable pa...
Eligibility Criteria
Inclusion
- All patients with an indication for the extracorporeal blood treatment suffering from renal insufficiency who received all treatments, between January 2019 and December 2019, with the investigational devices have to be included in the study in chronological order.
- For aHD patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration and effluent volume) for 50 % of the documented treatments.
- For cHD patients: availability of the ultrafiltration values for all treatments and at least one value for urea and creatinine per week
Exclusion
- Simultaneous use of another filter/adsorber for another form of therapy
Key Trial Info
Start Date :
October 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05282732
Start Date
October 7 2022
End Date
December 1 2025
Last Update
June 22 2025
Active Locations (2)
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1
Medizinische Hochschule Hannover
Hanover, Germany, 30625
2
Universitätsklinikum Jena
Jena, Germany, 07743