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

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Aug 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called double plasma cytokine adsorption with low-dose plasma exchange, or DPCAS+LPE, for patients suffering from hepatitis B-related acute-on-chronic liver failure (HBV-ACLF) who also have sepsis, a serious infection. The goal is to see if this treatment can help improve survival rates and reduce inflammation in these patients. Researchers will closely monitor how well the treatment works over a 12-week period, comparing results between those receiving DPCAS+LPE and those receiving standard plasma exchange therapy.

To participate in this trial, patients need to be between 18 and 65 years old and have specific health conditions, such as high bilirubin levels and signs of an infection that has recently worsened their condition. Eligible patients will undergo artificial liver therapy every other day for a total of two sessions and will be followed up at various times to assess their health. It's important to note that there are certain health issues that would exclude someone from participating, such as other liver diseases or severe organ failures. Overall, this study aims to explore a new potential treatment for a very serious condition, with the hope of improving outcomes for patients.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 65 years.
• • 2. Total bilirubin (TBIL) \> 12 mg/dL, 3\>INR ≥ 1.5.
• • 3. Meets the diagnostic criteria for sepsis 3.0: confirmed or suspected infection with an increase in SOFA score by ≥ 2 points.
• • 4. High inflammatory state: IL-6 \> 100 pg/ml.
• • 5. Persistent HBsAg or HBV DNA positivity for more than 6 months.
• • 6. Onset of sepsis within the past 72 hours.
• Exclusion Criteria:
• • 1. Presence of other causes of chronic liver disease, such as infection with other hepatotropic viruses, alcoholic liver disease, autoimmune liver disease, or genetic metabolic liver disease.
• • 2. Patients with liver malignancies or other concurrent cancers.
• • 3. Pregnancy or lactation.
• • 4. Patients with HIV infection or other immunodeficiency diseases.
• • 5. Patients with autoimmune diseases, recent cardiovascular events leading to unstable infarction, or a history of organ transplantation.
• 6. End-stage organ failure:
• • End-stage chronic obstructive pulmonary disease, end-stage pulmonary heart disease, brain death, or persistent vegetative state, Grade IV hepatic encephalopathy.
• • End-stage renal disease or acute renal failure requiring CRRT. Inability to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation, vasopressors, and steroid therapy.
• • 7. Platelet count \< 50×10⁹/L, severe coagulopathy, or active bleeding.
• • 8. Allergic reactions to extracorporeal circulation, hemoperfusion substances, or history of severe allergies.
• • 9. Inability to comply with study protocols or refusal to sign the informed consent form.
• • 10. Inability to attend regular follow-up visits according to the study schedule.
• • 11. Any other conditions that, in the investigator's judgment, make the patient unsuitable for inclusion in the study.