Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients

Launched by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Mar 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well certain filters and concentrates work for patients undergoing haemodialysis, a treatment for severe kidney problems. Specifically, it focuses on the Genius SleddFlux Filter, Ultraflux AV 600 S Filter, and Genius 90 Concentrates in different groups of patients, including those in acute kidney failure and those with chronic kidney disease. The goal is to analyze the treatment data to see how these devices perform and if they help improve kidney function in patients who need this life-saving treatment.

To participate in this trial, patients should be 65 years or older and have been treated with the filters during 2019 for their kidney issues. They need to have certain health measurements recorded to ensure their treatment can be evaluated properly. Eligible participants can expect their past treatment data to be reviewed, which means they won’t have to undergo any new procedures. It's important to note that patients using other filters or therapies during the same time won't be included in the study. This trial is currently recruiting participants, and anyone interested should talk to their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Simultaneous use of another filter/adsorber for another form of therapy