The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKDNCT06989892
Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial
A study testing Super High-flux dialyzer (Elisio 19HDx) and High-flux dialyzer (Elisio 19H) in people with The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD and End Stage Kidney Disease (ESRD), run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
Comparing the efficacy of superhigh-flux dialyzer with high-flux dialyzer in ESKD patient who have sepsis to improve mortality and sepsis outcome, an open label randomized control trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD, End Stage Kidney Disease (ESRD), Sepsis
- What is being tested?
- Super High-flux dialyzer (Elisio 19HDx) and High-flux dialyzer (Elisio 19H)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jul 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESKD patients who have sepsis condition with high interleukin-6 (IL-6 > 50 pg/ml)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Navamindhradhiraj university
Dusit, Bangkok, 11130
Punnawit Laungchuaychok, MD, 022443000, punnawit@nmu.ac.th
Wanjak Pongsittisak, MD
About this study
Comparing the efficacy of superhigh-flux dialyzer with high-flux dialyzer in ESKD patient who have sepsis to improve mortality and sepsis outcome, an open label randomized control trial.
Read the detailed description
Sepsis in people who have ESKD is the risk of developing poor outcome. Cytokines play a role in the process of sepsis and cause the worsening clinical outcome despite definitive antibiotic treatment. Superhigh-flux dialyzer has a larger molecular weight cut off (MWCO) clearance, include cytokine, could contribute to improved sepsis management in individuals with ESKD. This study is conducted to prove the efficacy of super high-flux dialyzer comparing with high-flux dialyzer in case of mortality reduction for regular hemodialysis ESKD patients.
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
- The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD, End Stage Kidney Disease (ESRD), Sepsis
- Being tested
- Super High-flux dialyzer (Elisio 19HDx), High-flux dialyzer (Elisio 19H)
- Keywords
- Superhighflux, hemodialysis, end stage kidney disease, sepsis
- Medical subject headings
- Kidney Failure, Chronic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super High-flux dialyzer (Elisio 19HDx)Device
Dialysis with Super High-flux dialyzer for intervention group
High-flux dialyzer (Elisio 19H)Device
Dialysis with High-flux dialyzer for control group
| Study group | Role | What they receive |
|---|---|---|
| ESKD patient with sepsis who dialyzed with super high flux | Experimental | Patients received dialysis with Superhigh-flux dialyzer Receives: Device: Super High-flux dialyzer (Elisio 19HDx) |
| ESKD with sepsis who dialyzed with high flux dialyzer | Active comparator | Patients received dialysis with High-flux dialyzer Receives: Device: High-flux dialyzer (Elisio 19H) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the reduction of all cause death at 28 days
Comparing the efficacy to reduce all cause death at 28 days between Super High-flux dialyzer with High-flux dialyzer in ESKD with sepsis
Measured: 28 days
Secondary outcomes (7)
Comparing the difference of blood level of IL-6, ESR, CRP and albumin, before and after of the first dialysis session, in each group.
Measured: 7 days
The duration of inotrope weaning
Measured: 14 days
The duration of hospitalization
Measured: 28 days
Ventilator free days
Measured: 28 days
The incidence of intradialytic hypotension
Measured: 28 days
The incidence rate of complication of dialyzer in each group
The incidence rate of complication of dialyzer; allergic reaction, clotting of dialyzer etc.
Measured: 28 days
The adequacy profile of dialysis in both groups
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start25 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing the mortality in sepsis condition between two groups of ESKD patient who underwent hemodialysis with superhighflux and highflux dialyzer
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punnawit Laungchuaychok, Navamindradhiraj University
- Investigators
- Punnawit Laungchuaychok, MD, Principal investigator, Navamindradhiraj UniversityWanjak Pongsittisak, MD, Study chair, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989892
- Sponsor's protocol ID
- 205/66
- Status last verified
- May 2025
- First submitted
- 24 Jul 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23860248Gharamti 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.
PubMed 36044827Sarnak 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.
PubMed 11012910Song 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.
PubMed 31718563Abe 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.
PubMed 35211304Pongsittisak 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.
PubMed 37231799
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06989892
- Acronym / sponsor ID
- 205/66
- Conditions
- The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD, End Stage Kidney Disease (ESRD), Sepsis
- Keywords
- Superhighflux, hemodialysis, end stage kidney disease, sepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the efficacy of superhigh-flux dialyzer with high-flux dialyzer in ESKD patient who have sepsis to improve mortality and sepsis outcome, an open label randomized control trial.
Detailed description
Sepsis in people who have ESKD is the risk of developing poor outcome. Cytokines play a role in the process of sepsis and cause the worsening clinical outcome despite definitive antibiotic treatment. Superhigh-flux dialyzer has a larger molecular weight cut off (MWCO) clearance, include cytokine, could contribute to improved sepsis management in individuals with ESKD. This study is conducted to prove the efficacy of super high-flux dialyzer comparing with high-flux dialyzer in case of mortality reduction for regular hemodialysis ESKD patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparing the mortality in sepsis condition between two groups of ESKD patient who underwent hemodialysis with superhighflux and highflux dialyzer
| Arm | Type | Receives |
|---|---|---|
| ESKD patient with sepsis who dialyzed with super high flux | Experimental | Device: Super High-flux dialyzer (Elisio 19HDx)Patients received dialysis with Superhigh-flux dialyzer |
| ESKD with sepsis who dialyzed with high flux dialyzer | Active comparator | Device: High-flux dialyzer (Elisio 19H)Patients received dialysis with High-flux dialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESKD patients who have sepsis condition with high interleukin-6 (IL-6 > 50 pg/ml)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super High-flux dialyzer (Elisio 19HDx)Dialysis with Super High-flux dialyzer for intervention group | Device | ESKD patient with sepsis who dialyzed with super high flux |
| High-flux dialyzer (Elisio 19H)Dialysis with High-flux dialyzer for control group | Device | ESKD with sepsis who dialyzed with high flux dialyzer |
Primary outcome
Comparing the reduction of all cause death at 28 days
Time frame: 28 days
Comparing the efficacy to reduce all cause death at 28 days between Super High-flux dialyzer with High-flux dialyzer in ESKD with sepsis
7 secondary outcomes
Comparing the difference of blood level of IL-6, ESR, CRP and albumin, before and after of the first dialysis session, in each group.
Time frame: 7 days
The duration of inotrope weaning
Time frame: 14 days
The duration of hospitalization
Time frame: 28 days
Ventilator free days
Time frame: 28 days
The incidence of intradialytic hypotension
Time frame: 28 days
The incidence rate of complication of dialyzer in each group
Time frame: 28 days
The adequacy profile of dialysis in both groups
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 23860248Zhou 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.
- Background: PubMed 36044827Gharamti 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.
- Background: PubMed 11012910Sarnak 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.
- Background: PubMed 31718563Song 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.
- Background: PubMed 35211304Abe 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.
- Background: PubMed 37231799Pongsittisak 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Punnawit Laungchuaychok, MD principal investigator
Navamindradhiraj University
Wanjak Pongsittisak, MD study chair
Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super High-flux dialyzer (Elisio 19HDx) and High-flux dialyzer (Elisio 19H) in people with The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD and End Stage Kidney Disease (ESRD), run by Navamindradhiraj University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Punnawit Laungchuaychok, MD (022443000, punnawit@nmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the reduction of all cause death at 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989892, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.