About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Simultaneous use of another filter/adsorber for another form of therapy
Trial population
Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system
Trial design
Other
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Daily values for urea, Unit: mg/dl or mmol/L
Acute haemodialysis patients
Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L
Acute haemodialysis patients
Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L
Acute haemodialysis patients
Ultrafiltration volume (UF) and Effluent volume (per treatment)
Acute haemodialysis patients
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fresenius Medical Care Deutschland GmbH
Lead sponsor
Alcedis GmbH
Collaborator