Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

February 12, 2013 updated by: Khajohn Tiranathanagul, Chulalongkorn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: On-line hemodiafiltration
pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min
Other Names:
  • Nikkiso dialysis machine
  • ARROW dual lumen dialysis catheter
  • PureFlux -150H synthetic membrane dialyzer
Active Comparator: 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.
Procedure: High-flux Hemodialysis
blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Khajohn Tiranathanagul, M.D., Chulalongkorn University
  • Principal Investigator: Wiwat Chancharoenthana, M.D., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KJWW367/53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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