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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05282732

Acronym

Genius

Enrollment

119

Registered

2022-03-16

Start date

2022-10-07

Completion date

2025-10-15

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, End Stage Renal Disease, Renal Failure

Keywords

Hemodialysis, Genius system, Slow extended daily dialysis

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Daily values for urea, Unit: mg/dl or mmol/L	During the intervention	Acute haemodialysis patients
Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L	During the intervention	Acute haemodialysis patients
Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L	During the intervention	Acute haemodialysis patients
Ultrafiltration volume (UF) and Effluent volume (per treatment)	During the intervention	Acute haemodialysis patients
Values for urea and creatinine (measured according to the clinical practice of the site)	During the intervention	Chronic haemodialysis patients
Planned and delivered UF-volume (per treatment)	During the intervention	Chronic haemodialysis patients

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORMartin Brauer, Dr. med.

Jena University Hospital

PRINCIPAL_INVESTIGATORBernhard Schmidt, Prof Dr med

Hannover Medical School

Outcome results