MedPath

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

Not Applicable
Completed
Conditions
Acute Kidney Injury
Sepsis
Registration Number
NCT03014232
Lead Sponsor
Chulalongkorn University
Brief Summary

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).

Detailed 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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
IL-6 ClearanceAt 30 minutes after the treatment was started

Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.

Secondary Outcome Measures
NameTimeMethod
Urea percentage of reduction ratioAt time 0-hour and 6-hour of the study SLED-f session

Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.

Beta2-microglobulin percentage of reduction ratioAt time 0-hour and 6-hour of the study SLED-f session

Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.

IL-10 ClearancesAt 30 minutes after the treatment was started

Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.

TNF-α ClearancesAt 30 minutes after the treatment was started

Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.

Intradialytic hypotensionDuring 6 hours of SLED-f session

The hypotensive events were records

Albumin loss in spent dialysateDuring 6 hours of SLED-f session

Continuous sampling of spent effluent dialysate and ultrafiltrate were carried out with a collection pump inserted into the effluent outlet line via a special connector for total albumin loss determination

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.