Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Recruiting · NCT05282732 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fresenius Medical Care Deutschland GmbH
View the official record on ClinicalTrials.gov →What this trial is 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Medizinische Hochschule Hannover - Hanover, Germany
- Universitätsklinikum Jena - Jena, Germany