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

Overview

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.

Interventions

• Device Super High-flux dialyzer (Elisio 19HDx)
  Dialysis with Super High-flux dialyzer for intervention group
• Device High-flux dialyzer (Elisio 19H)
  Dialysis with High-flux dialyzer for control group

Primary outcome measures

• Comparing the reduction of all cause death at 28 days [Time frame: 28 days]

Secondary outcome measures (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. [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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Thailand · 1 center

• Navamindhradhiraj university — Dusit

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. PMID 23860248
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06989892 · 205/66

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗