Evaluating a new treatment for liver failure and sepsis

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

This study is testing a new treatment for people with liver failure and sepsis to see if it can help them survive and improve their organ function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06562803 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a double plasma cytokine adsorption system combined with sequential low-dose plasma exchange in patients suffering from hepatitis B-related acute-on-chronic liver failure complicated by sepsis. The research focuses on determining whether this therapy can improve survival rates and various clinical scores related to organ function and inflammation. Patients will be randomly assigned to receive either the treatment or a control intervention, and outcomes will be measured over a 12-week period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with hepatitis B-related acute-on-chronic liver failure and recent onset sepsis.

Not a fit: Patients with other chronic liver diseases, liver malignancies, or severe immunodeficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and clinical outcomes for patients with severe liver failure and sepsis.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating severe liver conditions, suggesting potential for success.

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.

Where this trial is running

Guangzhou, Guangdong

• Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Liang Peng, Doctor — Third Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Liang Peng, Doctor

Conditions Acute-On-Chronic Liver Failure; Sepsis