Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
This study is like looking back through patient records to understand how certain dialysis filters and concentrates (special solutions) performed. It focuses on people with kidney failure, whether their kidney problems appeared suddenly (acute) or have been ongoing (chronic). The main goal is to see how well these devices worked for different patients, including those who were very unwell. Researchers also wanted to check the features of the filters used for sudden kidney problems and to see if patients' kidney function got better. This type of study helps doctors understand more about the everyday use of these treatments.
At a glance
What is this study about?
Imagine your kidneys aren't working properly to clean your blood. Doctors use a treatment called haemodialysis, which involves a machine that filters your blood for you. This study is like a detective story, where researchers are looking back at information already collected from patients who had haemodialysis.
They're specifically interested in two types of filters, called Genius SleddFlux Filter and Ultraflux AV 600 S Filter, and a special liquid called Genius 90 Concentrates. They want to understand how these specific products worked for real patients in real-life situations. This includes people whose kidneys suddenly stopped working, as well as those with long-term kidney problems.
The main reasons for this study were to see: 1) how well these filters and solutions did their job for patients, 2) what special features the filters had when used for sudden kidney failure, and 3) if patients' kidney function improved after using these treatments. By looking at information from medical records, doctors can learn more about how to best help people with kidney conditions.
Key takeaways
- This study looks at old records of patients who had kidney dialysis.
- It aims to understand how well certain filters and solutions worked for different kidney conditions.
- No new patient involvement, treatments, or tests are needed.
- The study focuses on adults who received dialysis between January 2019 and December 2019.
- Information gathered helps improve future care for people with kidney failure.
Who may be eligible?
To be included in this study, patients must have previously received blood-cleaning treatments due to kidney failure, specifically using the Genius SleddFlux Filter, Ultraflux AV 600 S Filter, or Genius 90 Concentrates. These treatments must have happened between January 2019 and December 2019.
If a patient had sudden (acute) kidney failure, there needed to be enough daily information available in their records about things like urea, creatinine (waste products in the blood), potassium, how much fluid was removed, and the amount of filtered waste.
For patients with long-term (chronic) kidney failure, there needed to be information about fluid removal for all treatments, and at least weekly records of their urea and creatinine levels. People who also used a different filter or absorber as part of another treatment at the same time would not have been included in this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Were you an adult (18 or older) when you had dialysis?
- Did you have dialysis for kidney failure between January 2019 and December 2019?
- Did you use Genius SleddFlux Filter, Ultraflux AV 600 S Filter, or Genius 90 Concentrates?
- Were you NOT using another different filter or treatment at the same time?
- If you had sudden kidney failure, was there enough daily information about your blood tests and fluid levels in your records?
- If you had long-term kidney failure, were your fluid levels and kidney test results recorded regularly?
What does participation involve?
This study is a 'retrospective analysis,' which means researchers are looking back at existing medical records and data that have already been collected. No new treatments, tests, or visits are required for patients. You would not be asked to do anything new or different if you were part of this study, as it's about information from past treatments. The total duration of involvement for each patient is limited to the period when their original treatment took place (January 2019 to December 2019) and the data was collected by the medical team at that time.
Potential risks and benefits
Locations (2)
- Medizinische Hochschule HannoverVerified postcodeHanover, Germany· Recruiting
- Universitätsklinikum JenaVerified postcodeJena, Germany· Recruiting
Common questions
What kind of patients were included in this study?
The study looked at records of adults (18 years and older) who had dialysis for kidney failure, either sudden or long-term, between January 2019 and December 2019.
What is 'retrospective analysis'?
It means researchers are looking back at information that was already collected during routine medical care, rather than asking patients to do anything new for the study.
Will I have to take new medicines or have extra tests?
No, this study only uses information from your past medical records. You would not need to do anything new.
What are 'Genius SleddFlux Filter' and 'Ultraflux AV 600 S Filter'?
These are specific types of filters used in haemodialysis machines to clean the blood when kidneys are not working properly. 'Genius 90 Concentrates' are special solutions used in the dialysis process.
What is 'haemodialysis'?
Haemodialysis is a treatment that uses a machine to filter waste, salt, and extra fluid from your blood when your kidneys can no longer do this work adequately.
How to find out more
Tatiana De los Rios
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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