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

Navamindradhiraj University

Status: Enrolling

Conditions: End Stage Kidney Disease (ESRD); The Efficacy and Safety for Super High-flux Dialyzer in Case of Sepsis in ESKD; Sepsis

Treatments: Device: Super High-flux dialyzer (Elisio 19HDx); Device: High-flux dialyzer (Elisio 19H)

Study type: Interventional

Funder types: Other

Identifiers

NCT06989892

205/66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

ESKD patient with sepsis who dialyzed with super high flux

Experimental group

Description:

Patients received dialysis with Superhigh-flux dialyzer

Treatment:

Device: Super High-flux dialyzer (Elisio 19HDx)

ESKD with sepsis who dialyzed with high flux dialyzer

Active Comparator group

Description:

Patients received dialysis with High-flux dialyzer

Treatment:

Device: High-flux dialyzer (Elisio 19H)