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

Fresenius Medical Care (FMC)

Status: Enrolling

Conditions: Renal Failure; End Stage Renal Disease; Acute Renal Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT05282732

Genius-AKI-01-D

Details and patient eligibility

About

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 patients and chronic haemodialysis patients

• to analyse performance and treatment data from patients treated with the investigational device
• to evaluate the filter characteristics for aHD (Acute haemodialysis) patients
• to evaluate the improvement of kidney function for aHD patients

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

aHD: Acute haemodialysis patients

cHD: Chronic haemodialysis patients