Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial

NCT06989892 | Recruiting

• 1 other identifier: 205/66
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  7 days

• The duration of inotrope weaning

  14 days

• The duration of hospitalization

  28 days

• Ventilator free days

  28 days

• The incidence of intradialytic hypotension

  28 days

Study Arms (2)

ESKD patient with sepsis who dialyzed with super high flux

EXPERIMENTAL

Patients received dialysis with Superhigh-flux dialyzer

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

Device: High-flux dialyzer (Elisio 19H)

Interventions

Super High-flux dialyzer (Elisio 19HDx) DEVICE

Dialysis with Super High-flux dialyzer for intervention group

ESKD patient with sepsis who dialyzed with super high flux

High-flux dialyzer (Elisio 19H) DEVICE

Dialysis with High-flux dialyzer for control group

ESKD with sepsis who dialyzed with high flux dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ESKD patients who have sepsis condition with high interleukin-6 (IL-6 \> 50 pg/ml)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navamindradhiraj University: lead

Study Sites (1)

Navamindhradhiraj university

Dusit, Bangkok, 11130, Thailand

RECRUITING

Related Publications (6)

• 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.

  PMID: 23860248 BACKGROUND

• 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.

  PMID: 36044827 BACKGROUND

• 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.

  PMID: 11012910 BACKGROUND

• 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.

  PMID: 31718563 BACKGROUND

• 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.

  PMID: 35211304 BACKGROUND

• 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.

  PMID: 37231799 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Failure, Chronic; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Punnawit Laungchuaychok, MD

  Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

• Wanjak Pongsittisak, MD

  Navamindradhiraj University

  STUDY CHAIR

Central Study Contacts

Punnawit Laungchuaychok, MD

CONTACT

022443000; punnawit@nmu.ac.th

Wanjak Pongsittisak, MD

CONTACT

022443000; wanjak@nmu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Comparing the mortality in sepsis condition between two groups of ESKD patient who underwent hemodialysis with superhighflux and highflux dialyzer

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: May 25, 2025
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

TH (1)