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

Phase

N/A

Condition

Soft Tissue Infections

Primary Biliary Cholangitis

Liver Failure

Treatment

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

plasma exchange

Clinical Study ID

NCT06562803

PL18

Ages 18-70
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 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

Inclusion Criteria:

Age between 18 and 70 years with a background of chronic liver disease, regardlessof the presence of cirrhosis.
Total bilirubin (TBIL) > 12 mg/dL.
International normalized ratio (INR) ≥ 1.5.
Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with asequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) Highinflammatory status: IL-6 > 80 pg/ml.

(6) Diagnosis of sepsis within the past 72 hours.

Exclusion

Exclusion Criteria:

Inherited metabolic liver disease (including Wilson's disease, hereditaryhemochromatosis, and alpha-1 antitrypsin deficiency).
Patients with hepatocellular carcinoma or other malignancies.
Pregnant or breastfeeding women.
Patients with human immunodeficiency virus (HIV) infection or other immunodeficiencydiseases (including active hematological malignancies, congenital immunodeficiencysyndromes, or those currently receiving high-dose systemic immunosuppressivetherapy).
Unstable phase of cerebrovascular events.
History of organ transplantation.
Patients with irreversible or terminal extrahepatic organ failure that precludessafe extracorporeal circulation or confounds the intervention: ①Terminal chronicobstructive pulmonary disease, terminal cor pulmonale, brain death, or persistentvegetative state, or Grade IV hepatic encephalopathy. ②Requirement for renalreplacement therapy (RRT) at the time of screening/enrollment. ③Despite adequatefluid resuscitation, vasopressors, and steroid treatment, unable to maintain meanarterial pressure above 65 mmHg.
Platelet count < 50×10E9/L, severe coagulation disorders (INR>3.5), or activebleeding.
Known allergies to extracorporeal circulation, hemoperfusion, or other severeallergic history.
Refusal by the patient or their legally authorized representative (LAR) toparticipate in the study, or sign the informed consent form.
Inability to return for regular follow-up visits as planned in the study.
Other conditions that, in the judgment of the researchers, make the patientunsuitable for enrollment.

Study Design