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

Phase

N/A

Condition

Liver Failure

Liver Disease

Soft Tissue Infections

Treatment

double plasma cytokine adsorption system with sequential low-dose plasma exchange

plasma exchange

Clinical Study ID

NCT06562803

PL18

Ages 18-65
All Genders

Study 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 hepatitis B-related acute-on-chronic liver failure (HBV-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 HBV-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

Inclusion Criteria:

Age between 18 and 65 years.
Total bilirubin (TBIL) > 12 mg/dL, 3>INR ≥ 1.5.
Meets the diagnostic criteria for sepsis 3.0: confirmed or suspected infection withan increase in SOFA score by ≥ 2 points.
High inflammatory state: IL-6 > 100 pg/ml.
Persistent HBsAg or HBV DNA positivity for more than 6 months.
Onset of sepsis within the past 72 hours.

Exclusion

Exclusion Criteria:

Presence of other causes of chronic liver disease, such as infection with otherhepatotropic viruses, alcoholic liver disease, autoimmune liver disease, or geneticmetabolic liver disease.
Patients with liver malignancies or other concurrent cancers.
Pregnancy or lactation.
Patients with HIV infection or other immunodeficiency diseases.
Patients with autoimmune diseases, recent cardiovascular events leading to unstableinfarction, or a history of organ transplantation.
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 maintaina mean arterial pressure above 65 mmHg despite adequate fluid resuscitation,vasopressors, and steroid therapy.
Platelet count < 50×10⁹/L, severe coagulopathy, or active bleeding.
Allergic reactions to extracorporeal circulation, hemoperfusion substances, orhistory of severe allergies.
Inability to comply with study protocols or refusal to sign the informed consentform.
Inability to attend regular follow-up visits according to the study schedule.
Any other conditions that, in the investigator's judgment, make the patientunsuitable for inclusion in the study.

Study Design

double plasma cytokine adsorption system with sequential low-dose plasma exchange

September 27, 2024

October 31, 2026

Connect with a study center

Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510630
China
Active - Recruiting

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