Clinical trial NCT01791712: Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Acute Kidney Injury
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level
timeFrame: At time 0-hour and 4-hour of the study dialysis session
Secondary outcomes:
measure: Intradialytic hypotension
timeFrame: During 4 hours of the study dialysis session
measure: Renal recovery (at 30 days)
timeFrame: participants will be followed for the renal recovery (dialysis-free) for the 30 days from the first initiation of dialysis
measure: Hospital patient mortality
timeFrame: participants will be followed for the duration of hospital stay (an expected average of 5 weeks)
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Khajohn Tiranathanagul, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Wiwat Chancharoenthana, M.D.
role: PRINCIPAL_INVESTIGATOR
References: