Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791712
• Other study ID #: KJWW367/53
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: February 12, 2013
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis

Intervention

Procedure:
• On-line hemodiafiltration
pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min
• High-flux Hemodialysis
blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level		At time 0-hour and 4-hour of the study dialysis session	Yes
Secondary	Intradialytic hypotension		During 4 hours of the study dialysis session	Yes
Secondary	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	Yes
Secondary	Hospital patient mortality	mortality during hospital admission	participants will be followed for the duration of hospital stay (an expected average of 5 weeks)	Yes