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

Primary Purpose

Sepsis, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SLED-f with HCO dialyzer
SLED-f with HF dialyzer
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sustained low-efficiency diafiltration (SLED-f), high cut-off dialyzer, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SLED-f with HCO dialyzer

    SLED-f with HF dialyzer

    Arm 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.

    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

    Outcomes

    Primary Outcome Measures

    IL-6 Clearance
    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

    Urea percentage of reduction ratio
    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
    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
    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
    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
    The hypotensive events were records
    Albumin loss in spent dialysate
    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

    Full Information

    First Posted
    January 4, 2017
    Last Updated
    January 5, 2017
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03014232
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis, Acute Kidney Injury
    Keywords
    sustained low-efficiency diafiltration (SLED-f), high cut-off dialyzer, cytokines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SLED-f with HCO dialyzer
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    SLED-f with HF dialyzer
    Arm Type
    Active Comparator
    Arm 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
    Intervention Type
    Procedure
    Intervention Name(s)
    SLED-f with HCO dialyzer
    Intervention Description
    Online SLED-f with high cut-off dialyzers were performed using the Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). Super-flux, Sureflux 150FH (Nipro Corporation, Osaka, Japan; cellulose triacetate material, pore size 78 A◦, Kuf 66.9 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).
    Intervention Type
    Procedure
    Intervention Name(s)
    SLED-f with HF dialyzer
    Intervention Description
    Online SLED-f with standard high-flux dialyzers were performed using the same Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). High-flux ELISIO 150H (Nipro Corporation, Osaka, Japan; polynephron material, pore size 50-60 A◦, Kuf 67 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).
    Primary Outcome Measure Information:
    Title
    IL-6 Clearance
    Description
    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.
    Time Frame
    At 30 minutes after the treatment was started
    Secondary Outcome Measure Information:
    Title
    Urea percentage of reduction ratio
    Description
    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.
    Time Frame
    At time 0-hour and 6-hour of the study SLED-f session
    Title
    Beta2-microglobulin percentage of reduction ratio
    Description
    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.
    Time Frame
    At time 0-hour and 6-hour of the study SLED-f session
    Title
    IL-10 Clearances
    Description
    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.
    Time Frame
    At 30 minutes after the treatment was started
    Title
    TNF-α Clearances
    Description
    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.
    Time Frame
    At 30 minutes after the treatment was started
    Title
    Intradialytic hypotension
    Description
    The hypotensive events were records
    Time Frame
    During 6 hours of SLED-f session
    Title
    Albumin loss in spent dialysate
    Description
    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
    Time Frame
    During 6 hours of SLED-f session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khajohn Tiranathanagul, MD
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jeeraluk Tunpornchai, MD
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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