Actively Recruiting
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-04-30
192
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) in patients with acute-on-chronic liver failure (ACLF) complicated by sepsis. The focus is on assessing the impact of the cytokine adsorption column(CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) on survival rates, inflammation markers, and organ function to determine its potential value in clinical practice. The primary research questions are: (1) Does DPCAS+LPE artificial liver therapy improve the 4-week mortality rate in ACLF patients with sepsis? (2) Does it improve the 12-week mortality rate in these patients? Additionally, the study examines the effects of this therapy on APACHE II scores, SOFA scores, vasoactive-inotropic score, MELD scores, and COSSH-ACLF II scores, as well as the cytokine adsorption efficiency of the CA280. Patients were randomly assigned to either the DPCAS+LPE group or the plasma exchange(PE) group. All patients received artificial liver therapy every other day, for a total of two sessions. Follow-up assessments were conducted before and after each therapy session, as well as at 1, 2, 3, 4, and 12 weeks.
CONDITIONS
Official 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 (TBIL) greater than 12 mg/dL
- International normalized ratio (INR) of 1.5 or higher
- Meet sepsis criteria with confirmed or suspected infection and SOFA score increase of 2 or more points
- High inflammatory status with interleukin-6 (IL-6) levels above 80 pg/ml
- Diagnosis of sepsis within the last 72 hours
You will not qualify if you...
- Inherited metabolic liver diseases such as Wilson's disease, hereditary hemochromatosis, or alpha-1 antitrypsin deficiency
- Diagnosis of hepatocellular carcinoma or other cancers
- Pregnant or breastfeeding women
- Infection with HIV or other immunodeficiency diseases, including active blood cancers or congenital immune disorders, or currently on high-dose immunosuppressive therapy
- Unstable cerebrovascular events
- History of organ transplantation
- Irreversible or terminal organ failure preventing safe extracorporeal circulation, including terminal COPD, terminal cor pulmonale, brain death, persistent vegetative state, or Grade IV hepatic encephalopathy
- Need for renal replacement therapy at screening or enrollment
- Unable to maintain mean arterial pressure above 65 mmHg despite treatment
- Platelet count below 50 x 10^9/L, severe coagulation disorders (INR over 3.5), or active bleeding
- Known allergies to extracorporeal circulation or hemoperfusion
- Refusal to participate or inability to provide informed consent
- Inability to attend regular follow-up visits
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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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
CONTACT
W
Wenxiong Xu, Doctor
CONTACT
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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