Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients

Chulalongkorn University

Status: Completed

Conditions: Acute Kidney Injury; Sepsis

Treatments: Procedure: SLED-f with HF dialyzer; Procedure: SLED-f with HCO dialyzer

Study type: Interventional

Funder types: Other

Identifiers

NCT03014232

271/54

Details and patient eligibility

About

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).

Full description

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). Reductions of these cytokines have been reported to improve clinical outcomes. Online sustained low-efficiency diafiltration(SLED-f) using traditional high-flux(HF) dialyzer could remove some cytokines. Interestingly, the potential of enhancing cytokine removal by using newly designed high cut-off(HCO) dialyzer that could theoretically remove larger molecular weight solutes has never been studied in SLED-f before.This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f,n=8) and HF dialyzer(HF-SLED-f,n=8).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sepsis
• Acute kidney injury stage 3

Exclusion criteria

• Profound hemodynamic instability with more than one inotropic drug
• Pregnancy
• Breast-feeding
• Delayed receiving antibiotic up to 6 hours after beginning of septic shock.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

SLED-f with HCO dialyzer

Experimental group

Description:

Online sustained low-efficiency diafiltration (online SLED-f) using novel high cut-off dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of cytokine removals with the control arm.

Treatment:

Procedure: SLED-f with HCO dialyzer

SLED-f with HF dialyzer

Active Comparator group

Description:

Online sustained low-efficiency diafiltration (online SLED-f) using standard high-flux dialyzer in septic acute kidney injury patients was assigned as the control group

Treatment:

Procedure: SLED-f with HF dialyzer