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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable sepsis
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedFebruary 15, 2013
February 1, 2013
1.7 years
October 11, 2011
February 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level
At time 0-hour and 4-hour of the study dialysis session
Secondary Outcomes (3)
Intradialytic hypotension
During 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 mortality
participants will be followed for the duration of hospital stay (an expected average of 5 weeks)
Study Arms (2)
On-line hemodiafiltration
EXPERIMENTALOn-line hemodiafiltration is a type of renal replacement therapy that was assigned as the intervention to compare with the control arm
High-flux hemodialysis (control)
ACTIVE COMPARATORThe 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.
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
Eligibility Criteria
You may qualify if:
- Sepsis
- acute kidney injury (RIFLE classification F)
- Age more than 18
You may not qualify if:
- Hemodynamic instability
- Whom written informed consent could not be obtained
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khajohn Tiranathanagul, M.D.
Chulalongkorn University
- PRINCIPAL INVESTIGATOR
Wiwat Chancharoenthana, M.D.
Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 11, 2011
First Posted
February 15, 2013
Study Start
January 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 15, 2013
Record last verified: 2013-02