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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFresenius Medical Care Deutschland GmbH

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: aHD: Acute haemodialysis patients
Group B: cHD: Chronic haemodialysis patients

Trial outcomes

Primary outcomes

1

Daily values for urea, Unit: mg/dl or mmol/L

Acute haemodialysis patients

Time frame
During the intervention
2

Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L

Acute haemodialysis patients

Time frame
During the intervention
3

Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L

Acute haemodialysis patients

Time frame
During the intervention
4

Ultrafiltration volume (UF) and Effluent volume (per treatment)

Acute haemodialysis patients

Time frame
During the intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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