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

February 22, 2024 updated by: Fresenius Medical Care Deutschland GmbH

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
aHD: Acute haemodialysis patients
cHD: Chronic haemodialysis patients

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

Alcedis GmbH

Investigators

  • Principal Investigator: Martin Brauer, Dr. med., Universitätsklinikum Jena
  • Principal Investigator: Bernhard Schmidt, Prof Dr med, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Genius-AKI-01-D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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