Blood purification and mortality in sepsis: a meta-analysis of randomized trials.
Feihu Zhou, Zhiyong Peng, Raghavan Murugan...
https://pubmed.ncbi.nlm.nih.gov/23860248Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06989892
Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patients With Sepsis: a Randomized Control Trial
Led by Navamindradhiraj University · Updated on 2025-05-25
202
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
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 pg/ml) 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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with end-stage kidney disease (ESKD) and sepsis
- Have high interleukin-6 (IL-6) levels greater than 50 pg/ml
You will not qualify if you...
- Patients requiring continuous kidney replacement therapy
- Vulnerable patients including pregnant women
- Patients expected to pass away within 24 hours
- History of allergic reaction to dialyzers used in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Navamindhradhiraj university
Dusit, Bangkok, Thailand, 11130
Actively Recruiting
Loading map...
Research Team
P
Punnawit Laungchuaychok, MD
W
Wanjak Pongsittisak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
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.
Amal A Gharamti, Omar Samara, Anthony Monzon...
https://pubmed.ncbi.nlm.nih.gov/36044827Mortality caused by sepsis in patients with end-stage renal disease compared with the general population.
M J Sarnak, B L Jaber
https://pubmed.ncbi.nlm.nih.gov/11012910Diagnostic 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.
Juhyun Song, Dae Won Park, Sungwoo Moon...
https://pubmed.ncbi.nlm.nih.gov/31718563Super high-flux membrane dialyzers improve mortality in patients on hemodialysis: a 3-year nationwide cohort study.
Masanori Abe, Ikuto Masakane, Atsushi Wada...
https://pubmed.ncbi.nlm.nih.gov/35211304Medium Cut-Off versus Low-Flux Dialyzers in Hemodialysis Patients with COVID-19: Clinical Outcomes and Reduction in Interleukin-6.
Wanjak Pongsittisak, Panchalee Satpanich, Solos Jaturapisanukul...
https://pubmed.ncbi.nlm.nih.gov/37231799