Clinical trial NCT03014232: Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients
Official title: Comparison Cytokine Clearance Between Sustained Low-Efficiency Diafiltration (SLED-f) Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Acute Kidney Injury
Keywords: sustained low-efficiency diafiltration (SLED-f)
high cut-off dialyzer
cytokines
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: IL-6 Clearance
timeFrame: At 30 minutes after the treatment was started
Secondary outcomes:
measure: Urea percentage of reduction ratio
timeFrame: At time 0-hour and 6-hour of the study SLED-f session
measure: Beta2-microglobulin percentage of reduction ratio
timeFrame: At time 0-hour and 6-hour of the study SLED-f session
measure: IL-10 Clearances
timeFrame: At 30 minutes after the treatment was started
measure: TNF-α Clearances
timeFrame: At 30 minutes after the treatment was started
measure: Intradialytic hypotension
timeFrame: During 6 hours of SLED-f session
measure: Albumin loss in spent dialysate
timeFrame: During 6 hours of SLED-f session
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Khajohn Tiranathanagul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Jeeraluk Tunpornchai, MD
role: PRINCIPAL_INVESTIGATOR
References: