Comparing two types of dialyzers for ESKD patients with sepsis
Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial
This study is testing whether a new type of dialyzer can help patients with end-stage kidney disease and sepsis live longer and have better health outcomes compared to a standard dialyzer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Navamindradhiraj University Academic / other |
| Locations | 1 site (Dusit, Bangkok) |
| Trial ID | NCT06989892 on ClinicalTrials.gov |
What this trial studies
This study compares the efficacy of super high-flux dialyzers to high-flux dialyzers in patients with end-stage kidney disease (ESKD) who are experiencing sepsis. It is an open-label, single-center, randomized control trial that aims to determine if the super high-flux dialyzer can improve mortality rates and outcomes in these patients. Participants will be randomly assigned to one of the two dialyzer groups, with a focus on those exhibiting high levels of interleukin-6. The primary endpoint of the study is mortality within 28 days of treatment.
Who should consider this trial
Good fit: Ideal candidates are ESKD patients with sepsis and elevated interleukin-6 levels.
Not a fit: Patients requiring continuous kidney replacement therapy or those expected to pass away within 24 hours will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and better management of sepsis in ESKD patients.
How similar studies have performed: While this approach is novel in the context of ESKD and sepsis, similar studies have shown promising results with high-flux dialyzers in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ESKD patients who have sepsis condition with high interleukin-6 (IL-6 \> 50 pg/ml) Exclusion Criteria: * Patients who needed dialysis with continuous kidney replacement therapy, vulnerable patient, include pregnant woman, patient who expected to pass away within the 24 hours. * Patients who have the history of allergic dialyzer reaction to dialyzer which used in this trial.
Where this trial is running
Dusit, Bangkok
- Navamindhradhiraj university — Dusit, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Punnawit Laungchuaychok, MD — Navamindradhiraj University
- Study coordinator: Punnawit Laungchuaychok, MD
- Email: punnawit@nmu.ac.th
- Phone: 022443000
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.