Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With HBV-ACLF and Sepsis
NCT Number: NCT06562803
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute-On-Chronic Liver Failure|Sepsis
Interventions: DEVICE: double plasma cytokine adsorption system with sequential low-dose plasma exchange|OTHER: plasma exchange
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2026-10-31

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.

Primary Outcome Measures: Mortality rate, 4-week mortality rate, 4 weeks
Secondary Outcome Measures: Mortality rate, 12-week Mortality rate, 12 weeks|Changes in Acute Physiology and Chronic Health Evaluation II score from baseline, The theoretical maximum value of Acute Physiology and Chronic Health Evaluation II score（APACHE II score） was 71 points. The higher the score, the higher the risk of death. Patients with more than 15 points were classified as severe, and patients with less than 15 points were classified as non-severe., 1, 2, 3, and 4 weeks|Changes in sequential organ failure assessment score from baseline, The theoretical value range of sequential organ failure assessment（SOFA） score is 6-24. The higher the score, the worse the prognosis., 1, 2, 3, and 4 weeks|Changes in vasoactive-inotropic score from baseline, Vasoactive-Inotropic Score ( VIS ) evaluates cardiac function and the intensity of vasoactive drug therapy in critically ill patients by quantifying the dose of vasoactive and inotropic drugs received by patients. VIS has no special value range. The higher the score, the higher the patient 's dependence on vasoactive drugs., 1, 2, 3, and 4 weeks|Changes in Model for End-Stage Liver Disease score from baseline, MELD score is now widely used in the prioritization of liver transplantation candidates in many countries. The score range is usually between 6 ( low risk ) and 40 ( high risk )., 1, 2, 3, and 4 weeks|Changes in COSSH-ACLF II score from baseline, COSSH-ACLF II is a prognostic scoring system for hepatitis B virus -related acute-on-chronic liver failure（HBV-ACLF）. COSSH-ACLF IIs can significantly divide ACLF patients into three risk groups based on two cutoff values of 7.4 and 8.4 : low-risk group ( \< 7.4 points ), medium-risk group ( 7.4-8.4 points ) and high-risk group ( ≥ 8.4 points )., 1, 2, 3, and 4 weeks|Adsorption rates of various cytokines, Adsorption rates of various cytokines (including pro-inflammatory and anti-inflammatory cytokines) after each treatment, Day2, Day4|Adsorption rates of lactate, Adsorption rates of lactate after each treatment, Day2, Day4