Clinical trial NCT05282732: Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Failure
End Stage Renal Disease
Acute Renal Failure
Keywords: Hemodialysis
Genius system
Slow extended daily dialysis
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Alcedis GmbH
First posted: 2022-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system

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


Eligibility criteria: 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

Primary outcomes:
measure: Daily values for urea, Unit: mg/dl or mmol/L
timeFrame: During the intervention
measure: Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L
timeFrame: During the intervention
measure: Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L
timeFrame: During the intervention
measure: Ultrafiltration volume (UF) and Effluent volume (per treatment)
timeFrame: During the intervention
measure: Values for urea and creatinine (measured according to the clinical practice of the site)
timeFrame: During the intervention
measure: Planned and delivered UF-volume (per treatment)
timeFrame: During the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitätsklinikum Jena
Study officials:
affiliation: Jena University Hospital
name: Martin Brauer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Bernhard Schmidt, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: