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Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01791712
Enrollment
28
Registered
2013-02-15
Start date
2010-01-31
Completion date
2011-10-31
Last updated
2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Sepsis

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.

Interventions

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

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

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Reduction in plasma Vascular Endothelial Growth Factor (VEGF)levelAt time 0-hour and 4-hour of the study dialysis session

Secondary

MeasureTime frameDescription
Intradialytic hypotensionDuring 4 hours of the study dialysis session
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
Hospital patient mortalityparticipants will be followed for the duration of hospital stay (an expected average of 5 weeks)mortality during hospital admission

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026