Evaluating a new treatment for liver failure and sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: pliang@mail.sysu.edu.cn
• Phone: +8613533978874

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.