Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Study Overview
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Brief Summary
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Following the concept of peak concentration hypothesis, which suggest the cutting peak of pro- and anti-inflammatory mediators would result in restoring a situation of immunohomeostasis. The investigators conducted the prospective randomized controlled trial aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level during sepsis is postulated to improved outcomes in sepsis.

Detailed Description
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Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session. The percentage of reductions were calculated from the before and ending samples. The values of postfilter samples were corrected for changes in plasma volume, based on hemoglobin (Hb) of prefilter. VEGF and other cytokines (IL-6, IL-8, IL-10, and TNF-α) were determined in the plasma separated from EDTA blood. After collection, plasma separation was achieved by centrifugation for 10 min at 1,500 g. Immediately after separation, the samples were stored at -70 ºC until further analysis. All determinations were carried out in duplicate. The panels of cytokines (VEGF, IL-6, IL-8, IL-10, and TNF-α) were measured using the Luminex xMap-based multiplex technology. Assays were performed using the MILLIPLEX MAP (multi-analyte panels) 5-plex Cytokine Kit (Millipore, Billerica, MA) on the Luminex® instrument according to the manufacturer's procedure.

Official Title
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Enhanced Vascular Endothelial Growth Factor and Pro-inflammatory Cytokine Clearances With On-line Hemodiafiltration Versus High-flux Hemodialysis in Sepsis-related Acute Kidney Injury Patients

Conditions
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Sepsis, Acute Kidney Injury

Intervention / Treatment
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* Procedure: On-line hemodiafiltration
* Procedure: High-flux Hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sepsis acute kidney injury (RIFLE classification F) Age more than 18 Exclusion Criteria: Hemodynamic instability Whom written informed consent could not be obtained

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-line hemodiafiltration<br>On-line hemodiafiltration is a type of renal replacement therapy that was assigned as the intervention to compare with the control arm | Procedure: On-line hemodiafiltration<br>* pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min<br>* Other names: PureFlux -150H synthetic membrane dialyzer;|
| Active Comparator: High-flux hemodialysis (control)<br>The standard high-flux hemodialysis is the routine renal replacement therapy in sepsis-related acute kidney injury patients and is assigned as the intervention for the control group. | Procedure: High-flux Hemodialysis<br>* blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level |  | At time 0-hour and 4-hour of the study dialysis session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intradialytic hypotension |  | During 4 hours of the study dialysis session | 
| Renal recovery (at 30 days) |  | participants will be followed for the renal recovery (dialysis-free) for the 30 days from the first initiation of dialysis | 
| Hospital patient mortality | mortality during hospital admission | participants will be followed for the duration of hospital stay (an expected average of 5 weeks) |