Analysis of treatment data for specific filters used in hemodialysis 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
This study looks at how well different filters used in hemodialysis help improve kidney function in patients with acute and chronic kidney failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fresenius Medical Care Deutschland GmbH Industry-sponsored |
| Locations | 2 sites (Hanover and 1 other locations) |
| Trial ID | NCT05282732 on ClinicalTrials.gov |
What this trial studies
This observational study conducts a retrospective analysis of performance and treatment data from patients undergoing hemodialysis using the Genius SleddFlux Filter, Ultraflux AV 600 S Filter, and Genius 90 Concentrates. It aims to evaluate the effectiveness of these filters in both acute and chronic renal failure patients, focusing on key performance indicators such as urea and creatinine levels. The study includes data from patients treated between January and December 2019, assessing their kidney function improvement and overall treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with renal insufficiency who received treatment with the specified filters during the study period.
Not a fit: Patients who were treated with other filters or adsorbers simultaneously may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of filter performance in hemodialysis, potentially leading to improved treatment protocols for renal failure patients.
How similar studies have performed: While this study utilizes established filters, the retrospective analysis approach is common, and similar studies have shown varying degrees of success in evaluating hemodialysis treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanover and 1 other locations
- Medizinische Hochschule Hannover — Hanover, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Germany (Recruiting)
Study contacts
- Principal investigator: Martin Brauer, Dr. med. — Jena University Hospital
- Study coordinator: Tatiana De los Rios
- Email: Tatiana.De-Los-Rios@fmc-ag.com
- Phone: +49 6172 608 2362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.