Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

NCT ID: NCT01791712

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Sepsis; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

On-line hemodiafiltration

Intervention Type: PROCEDURE

pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

High-flux hemodialysis (control)

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.

Group Type: ACTIVE_COMPARATOR

High-flux Hemodialysis

Intervention Type: PROCEDURE

blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

Interventions

On-line hemodiafiltration

pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

Intervention Type: PROCEDURE

High-flux Hemodialysis

blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

Intervention Type: PROCEDURE

Other Intervention Names

Nikkiso dialysis machine; ARROW dual lumen dialysis catheter; PureFlux -150H synthetic membrane dialyzer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Khajohn Tiranathanagul

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khajohn Tiranathanagul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Wiwat Chancharoenthana, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

KJWW367/53

Identifier Type: -

Identifier Source: org_study_id