Acute Kidney Injury, Sepsis
Conditions
Keywords
sustained low-efficiency diafiltration (SLED-f), high cut-off dialyzer, cytokines
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).
Interventions
PROCEDURESLED-f with HCO dialyzer
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).
PROCEDURESLED-f with HF dialyzer
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).
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
Outcome results
None listed