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
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
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
NCT ID
NCT03014232
First Posted
January 4, 2017
Last Updated
January 5, 2017
Sponsor
Chulalongkorn University
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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