Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial
NCT ID: NCT06989892
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
202 participants
INTERVENTIONAL
2024-07-25
2026-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Super High-Flux - High Volume Dialysis in Sepsis-Induced Acute Renal Failure
NCT00333593
Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients
NCT03014232
Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal
NCT01791712
Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Hemodialysis Filter
NCT05941624
A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
NCT02433210
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Method This study is an open label single center randomized control trial. We randomized ESKD patients who have sepsis condition with high interleukin-6 (IL-6 \> 50 pg/ml).
The participants were allocated to super high-flux dialyzer group and high flux dialyzer group, stratified with diabetes, vascular access, and septic shock.
We excluded; patient who needed dialysis with continuous kidney replacement therapy, vulnerable patient, include pregnant woman, patient who closed and patient who expected to pass away within the 24 hours. We aim to enroll total 202 participants; divided equally in each arm. According to our protocol, non reused super high-flux dialyzer and high-flux dialyzer are used in the same assigned patient in first week without crossing over. The standard of care of sepsis and antibiotic are provided in both groups without intervening of researcher and our protocol. The primary endpoint is 28 days of mortality. The secondary outcome include cardiovascular death, rate reduction of IL-6 after dialysis, days of hospitalization, ventilator free days and complication of dialysis are also monitored.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ESKD patient with sepsis who dialyzed with super high flux
Patients received dialysis with Superhigh-flux dialyzer
Super High-flux dialyzer (Elisio 19HDx)
Dialysis with Super High-flux dialyzer for intervention group
ESKD with sepsis who dialyzed with high flux dialyzer
Patients received dialysis with High-flux dialyzer
High-flux dialyzer (Elisio 19H)
Dialysis with High-flux dialyzer for control group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Super High-flux dialyzer (Elisio 19HDx)
Dialysis with Super High-flux dialyzer for intervention group
High-flux dialyzer (Elisio 19H)
Dialysis with High-flux dialyzer for control group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients who have the history of allergic dialyzer reaction to dialyzer which used in this trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Navamindradhiraj University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Punnawit Laungchuaychok
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Punnawit Laungchuaychok, MD
Role: PRINCIPAL_INVESTIGATOR
Navamindradhiraj University
Wanjak Pongsittisak, MD
Role: STUDY_CHAIR
Navamindradhiraj University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Navamindhradhiraj university
Dusit, Bangkok, Thailand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Zhou F, Peng Z, Murugan R, Kellum JA. Blood purification and mortality in sepsis: a meta-analysis of randomized trials. Crit Care Med. 2013 Sep;41(9):2209-20. doi: 10.1097/CCM.0b013e31828cf412.
Gharamti AA, Samara O, Monzon A, Montalbano G, Scherger S, DeSanto K, Chastain DB, Sillau S, Montoya JG, Franco-Paredes C, Henao-Martinez AF, Shapiro L. Proinflammatory cytokines levels in sepsis and healthy volunteers, and tumor necrosis factor-alpha associated sepsis mortality: A systematic review and meta-analysis. Cytokine. 2022 Oct;158:156006. doi: 10.1016/j.cyto.2022.156006. Epub 2022 Aug 28.
Sarnak MJ, Jaber BL. Mortality caused by sepsis in patients with end-stage renal disease compared with the general population. Kidney Int. 2000 Oct;58(4):1758-64. doi: 10.1111/j.1523-1755.2000.00337.x.
Song J, Park DW, Moon S, Cho HJ, Park JH, Seok H, Choi WS. Diagnostic and prognostic value of interleukin-6, pentraxin 3, and procalcitonin levels among sepsis and septic shock patients: a prospective controlled study according to the Sepsis-3 definitions. BMC Infect Dis. 2019 Nov 12;19(1):968. doi: 10.1186/s12879-019-4618-7.
Abe M, Masakane I, Wada A, Nakai S, Nitta K, Nakamoto H. Super high-flux membrane dialyzers improve mortality in patients on hemodialysis: a 3-year nationwide cohort study. Clin Kidney J. 2021 Sep 28;15(3):473-483. doi: 10.1093/ckj/sfab177. eCollection 2022 Mar.
Pongsittisak W, Satpanich P, Jaturapisanukul S, Keawvichit R, Prommool S, Trakranvanich T, Ngamvichukorn T, Kurathong S. Medium Cut-Off versus Low-Flux Dialyzers in Hemodialysis Patients with COVID-19: Clinical Outcomes and Reduction in Interleukin-6. Blood Purif. 2023;52(6):591-599. doi: 10.1159/000530162. Epub 2023 May 5.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
205/66
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.