Comparing Super High-flux and High-flux Dialyzers for Hemodialysis Patients with Sepsis and End-Stage Kidney Disease
A Randomized Controlled Trial
Led by Navamindradhiraj University · Updated on 2025-05-25
202
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a super high-flux dialyzer compared to a high-flux dialyzer in patients with end-stage kidney disease ESKD who also have sepsis. The study aims to see if the super high-flux dialyzer can improve survival and sepsis outcomes by better removing cytokines, which are involved in worsening sepsis despite antibiotic treatment. This is an open-label, randomized control trial conducted at a single center.
Participants with ESKD and sepsis who have high levels of interleukin-6 greater than 50 pgml are randomly assigned to receive dialysis using either a super high-flux dialyzer or a high-flux dialyzer. The dialyzers are used without reuse during the first week, and standard sepsis care including antibiotics is provided to all participants without interference from the researchers. The study plans to enroll 202 participants, evenly divided between the two groups.
During the study, researchers will monitor mortality at 28 days as the primary outcome. Secondary outcomes include cardiovascular death, reduction in IL-6 levels after dialysis, length of hospital stay, ventilator-free days, and dialysis-related complications. Participants will be closely observed for complications such as intradialytic hypotension. The study duration for monitoring these outcomes is up to 28 days after treatment starts.
CONDITIONS
Brief Title
Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial
Research Team
P
Punnawit Laungchuaychok, MD
W
Wanjak Pongsittisak, MD
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History of allergic reaction to dialyzers used in this trial
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 28 days
Participants receive dialysis using either a super high-flux dialyzer or a high-flux dialyzer as assigned. Standard care for sepsis and antibiotics are provided without interference from the research team.
Dialysis sessions during the first week without crossover; visit frequency depends on dialysis schedule
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Proinflammatory cytokines levels in sepsis and healthy volunteers, and tumor necrosis factor-alpha associated sepsis mortality: A systematic review and meta-analysis.
Diagnostic and prognostic value of interleukin-6, pentraxin 3, and procalcitonin levels among sepsis and septic shock patients: a prospective controlled study according to the Sepsis-3 definitions.