Menu
Recruiting NCT05282732

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

— Observational Renal Failure End Stage Renal Disease Acute Renal Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Renal Failure, End Stage Renal Disease, Acute Renal Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Germany · 2 centers
  • Medizinische Hochschule Hannover — Hanover
  • Universitätsklinikum Jena — Jena

Identifiers

NCT: NCT05282732 · Genius-AKI-01-D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗