Actively Recruiting
Efficacy and Safety of Double Plasma Cytokine Adsorption System With Sequential Low-Dose Plasma Exchange in Treating Acute-on-Chronic Liver Failure and Sepsis: A Multi-center Randomized Controlled Study
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-04-30
192
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a double plasma cytokine adsorption system combined with sequential low-dose plasma exchange (DPCAS+LPE) in patients with acute-on-chronic liver failure (ACLF) complicated by sepsis. The study aims to determine if this therapy improves survival rates at 4 and 12 weeks, along with its effects on inflammation and organ function. Key measures include mortality rates and various clinical scoring systems related to liver disease severity and organ failure. Participants are randomly assigned to one of two groups. One group receives standard medical care plus two sessions of the DPCAS+LPE therapy followed by one session of plasma exchange (PE). The other group receives standard medical care along with three sessions of plasma exchange alone. Treatments are given every other day, and the DPCAS+LPE therapy uses specialized devices including a cytokine adsorption column and a bilirubin adsorption device during the sessions. Throughout the study, patients undergo assessments before and after each treatment session and at multiple follow-up points up to 12 weeks. These assessments include evaluations of survival, organ function scores (such as APACHE II, SOFA, MELD, and others), cytokine levels, and inflammation markers. Researchers closely monitor patients' responses to the therapies to understand their impact on disease progression and overall health outcomes.
CONDITIONS
Brief Title
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years with chronic liver disease, with or without cirrhosis
- Total bilirubin level greater than 12 mg/dL
- International normalized ratio (INR) of 1.5 or higher
- Diagnosis of sepsis with confirmed or suspected infection and a SOFA score increase of 2 points or more
- High inflammatory status with IL-6 level greater than 80 pg/ml
- Sepsis diagnosis made within the past 72 hours
You will not qualify if you...
- Inherited metabolic liver diseases such as Wilson's disease, hereditary hemochromatosis, or alpha-1 antitrypsin deficiency
- Presence of hepatocellular carcinoma or other cancers
- Pregnant or breastfeeding women
- HIV infection or other immunodeficiency diseases, including active blood cancers or current high-dose immunosuppressive therapy
- Unstable recent cerebrovascular events
- History of organ transplantation
- Irreversible or terminal organ failure preventing safe treatment, including terminal COPD, brain death, or severe hepatic encephalopathy
- Requirement for renal replacement therapy at screening
- Inability to maintain adequate blood pressure despite treatment
- Platelet count below 50 x 10^9/L, severe clotting disorders, or active bleeding
- Known severe allergies to extracorporeal circulation or hemoperfusion
- Refusal to participate or inability to consent
- Inability to attend regular follow-up visits
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 days
Participants receive either double plasma cytokine adsorption system with sequential low-dose plasma exchange or plasma exchange treatment every other day for a total of three sessions, alongside comprehensive medical care.
3 treatment sessions every other day
Duration - 12 weeks
Participants are monitored for safety and treatment outcomes including mortality and clinical scores up to 12 weeks after treatment.
Weekly visits for up to 4 weeks with additional assessments as needed
Trial Site Locations
Total: 1 location
1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
Research Team
L
Liang Peng, Doctor
W
Wenxiong Xu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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