Comparing isolated ultrafiltration to conventional hemodialysis in kidney disease patients
Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis
This study is testing if a new method called isolated ultrafiltration can help people with end-stage kidney disease have a better experience during dialysis compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT05642156 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of isolated ultrafiltration (iso-UF) on hemodynamic stability in patients with end-stage kidney disease undergoing hemodialysis. It aims to assess changes in peripheral resistance, osmolality, cardiac output, and cardiac power index, while exploring correlations with intradialytic hypotension (IDH) episodes. The study seeks to determine whether iso-UF can improve dialysis quality by reducing the time spent on dialysis compared to conventional methods. The research is motivated by the need for updated evidence on iso-UF's benefits, as previous studies may not reflect current techniques.
Who should consider this trial
Good fit: Ideal candidates are adults with end-stage kidney disease who are stable at their dry weight and experience significant interdialytic weight gain.
Not a fit: Patients with implanted medical devices, those treated with hemodiafiltration, or individuals with severe hyperkalemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular outcomes and reduced complications for patients undergoing hemodialysis.
How similar studies have performed: Previous studies on isolated ultrafiltration have shown limited success, indicating a need for further investigation into its efficacy with modern techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written consent of the participant after being informed * At least 18 years of age * End stage kidney disease patient undergoing hemodialysis * Dry weight stable for a minimum of one month * Interdialytic weight gain of \>2 liters in the short interdialytic interval Exclusion Criteria: * No informed consent was obtained * Patients with a pacemaker or implanted medical device that prevents compliance with study regulations * Patients treated with hemodiafiltration * Patients treated with medium cut-off membranes (Theranova, Baxter) * Patients with recurrent severe hyperkalemia after the short interdialytic interval (K+ concentration \> 6.0 mmol/L, requiring more than 2 hours of dialysis to ameliorate the post-dialytic shift from other compartments. * Women of childbearing age not using contraception
Where this trial is running
Graz
- Medical University of Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Alexander H Kirsch
- Email: alexander.kirsch@medunigraz.at
- Phone: +43316385
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.