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Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Sponsor
Chulalongkorn University (Other)
Overall Status
Completed
CT.gov ID
NCT01791712
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
21
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: On-line hemodiafiltration
  • Procedure: High-flux Hemodialysis
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level [At time 0-hour and 4-hour of the study dialysis session]

    Secondary Outcome Measures

    1. Intradialytic hypotension [During 4 hours of the study dialysis session]

    2. 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]

    3. Hospital patient mortality [participants will be followed for the duration of hospital stay (an expected average of 5 weeks)]

      mortality during hospital admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King Chulalongkorn Memorial Hospital Bangkok Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Khajohn Tiranathanagul, Doctor, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT01791712
    Other Study ID Numbers:
    • KJWW367/53
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Feb 15, 2013
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Sepsis
    Acute Kidney Injury

    Study Results

    No Results Posted as of Feb 15, 2013