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
• Interventions: Procedure: SLED-f with HF dialyzer; Procedure: SLED-f with HCO dialyzer

• 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).

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Last Update Submitted: 2017-01-05
• Study First Posted: 2017-01-09
• Last Update Posted: 2017-01-09

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

Arm && Interventions

Group	Intervention	Description
SLED-f with HF dialyzer	SLED-f with HF dialyzer	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
SLED-f with HCO dialyzer	SLED-f with HCO dialyzer	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.

Primary Outcome Measures

Name	Time	Method
IL-6 Clearance	At 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

Name	Time	Method
Urea percentage of reduction ratio	At 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 ratio	At 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 Clearances	At 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 Clearances	At 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 hypotension	During 6 hours of SLED-f session	The hypotensive events were records
Albumin loss in spent dialysate	During 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