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Completed

NCT Number: NCT01791712

Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

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.

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Key information

Conditions

Sepsis Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

About this study

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

on-line hemodiafiltration

Procedure

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

High-flux Hemodialysis

Procedure

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

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

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

    mortality during hospital admission

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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