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CompletedNCT01791712Updated Feb 15, 2013

Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

An interventional study of On-line hemodiafiltration and High-flux Hemodialysis in Sepsis and Acute Kidney Injury, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Sepsis
  • Acute Kidney Injury
03

In context

Sepsis

1,903 studies on the registry are indexed under Sepsis; 466 are open to participants now.

This study's enrollment of 28 is below the median of 105 across 899 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 313 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Sepsis
  • acute kidney injury (RIFLE classification F)
  • Age more than 18

Exclusion criteria

Exclusion Criteria:

  • Hemodynamic instability
  • Whom written informed consent could not be obtained
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureOn-line hemodiafiltration

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

    Also known as: Nikkiso dialysis machine, ARROW dual lumen dialysis catheter, PureFlux -150H synthetic membrane dialyzer

  • ProcedureHigh-flux Hemodialysis

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

06

What researchers measure

Primary outcomes

  1. Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level

    Time frame: At time 0-hour and 4-hour of the study dialysis session

Secondary outcomes

  1. Intradialytic hypotension

    Time frame: During 4 hours of the study dialysis session

  2. 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

  3. Hospital patient mortality

    mortality during hospital admission

    Time frame: participants will be followed for the duration of hospital stay (an expected average of 5 weeks)

07

Study locations

1 site
  • King Chulalongkorn Memorial Hospital
    Bangkok, 10330, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01791712
Lead sponsor
Chulalongkorn University
Responsible party
Khajohn Tiranathanagul (Doctor, Chulalongkorn University) — Principal investigator
First posted
Feb 15, 2013
Start date
Jan 2010
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Feb 15, 2013

Study contacts

Khajohn Tiranathanagul, M.D.
principal investigator · Chulalongkorn University
Wiwat Chancharoenthana, M.D.
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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