Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Not Applicable

Completed

• Conditions: Sepsis; Acute Kidney Injury
• Interventions: Procedure: On-line hemodiafiltration; Procedure: High-flux Hemodialysis

• Registration Number: NCT01791712
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

1. 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.

2. 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.

3. 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-11
• Status Verified: 2013-02
• Study First Submitted QC: 2013-02-12
• Last Update Submitted: 2013-02-12
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
On-line hemodiafiltration	On-line hemodiafiltration	On-line hemodiafiltration is a type of renal replacement therapy that was assigned as the intervention to compare with the control arm
High-flux hemodialysis (control)	High-flux Hemodialysis	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.

Primary Outcome Measures

Name	Time	Method
Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level	At time 0-hour and 4-hour of the study dialysis session

Secondary Outcome Measures

Name	Time	Method
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	participants will be followed for the duration of hospital stay (an expected average of 5 weeks)	mortality during hospital admission

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand