NCT06562803 Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis

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This trial targets 192 participants in total. It began in 2024-09-27 with a primary completion date of 2027-10-31.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age between 18 and 70 years with a background of chronic liver disease, regardless of the presence of cirrhosis. 2. Total bilirubin (TBIL) \> 12 mg/dL. 3. International normalized ratio (INR) ≥ 1.5. 4. Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with a sequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) High inflammatory status: IL-6 \> 80 pg/ml. (6) Diagnosis of sepsis within the past 72 hours. Exclusion Criteria: 1. Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, and alpha-1 antitrypsin deficiency). 2. Patients with hepatocellular carcinoma or other malignancies. 3. Pregnant or breastfeeding women. 4. Patients with human immunodeficiency virus (HIV) infection or other immunodeficiency diseases (including active hematological malignancies, congenital immunodeficiency syndromes, or those currently receiving high-dose systemic immunosuppressive therapy). 5. Unstable phase of cerebrovascular events. 6. History of organ transplantation. 7. Patients with irreversible or terminal extrahepatic organ failure that precludes safe extracorporeal circulation or confounds the intervention: ①Terminal chronic obstructive pulmonary disease, terminal cor pulmonale, brain death, or persistent vegetative state, or Grade IV hepatic encephalopathy. ②Requirement for renal replacement therapy (RRT) at the time of screening/enrollment. ③Despite adequate fluid resuscitation, vasopressors, and steroid treatment, unable to maintain mean arterial pressure above 65 mmHg. 8. Platelet count \< 50×10E9/L, severe coagulation disorders (INR\>3.5), or active bleeding. 9. Known allergies to extracorporeal circulation, hemoperfusion, or other severe allergic history. 10. Refusal by the patient or their legally authorized representative (LAR) to participate in the study, or sign the informed consent form. 11. Inability to return for regular follow-up visits as planned in the study. 12. Other conditions that, in the judgment of the researchers, make the patient unsuitable for enrollment.

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