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

Not Applicable

Recruiting

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

• Registration Number: NCT06989892
• Lead Sponsor: Navamindradhiraj University

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.

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 Timeline

• Study First Submitted: 2024-07-24
• Study Start: 2024-07-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-07-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparing the reduction of all cause death at 28 days	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

Secondary Outcome Measures

Name	Time	Method
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
The incidence of intradialytic hypotension	28 days
Ventilator free days	28 days
The incidence rate of complication of dialyzer in each group	28 days	The incidence rate of complication of dialyzer; allergic reaction, clotting of dialyzer etc.
The adequacy profile of dialysis in both groups	7 days

Trial Locations

Locations (1)

Navamindhradhiraj university; 🇹🇭 Dusit, Bangkok, Thailand