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

Recruiting

• Conditions: Renal Failure; End Stage Renal Disease; Acute Renal Failure

• Registration Number: NCT05282732
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2022-10-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Planned and delivered UF-volume (per treatment)	During the intervention	Chronic haemodialysis patients
Values for urea and creatinine (measured according to the clinical practice of the site)	During the intervention	Chronic haemodialysis patients
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

Trial Locations

Locations (2)

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany