Efficacy and Safety of Double Plasma Cytokine Adsorption System With Sequential Low-Dose Plasma Exchange in Treating Hepatitis B-Related Acute-on-Chronic Liver Failure and Sepsis: A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 with an 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.

Locations
Other Locations
China
Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Liang Peng, Doctor
pliang@mail.sysu.edu.cn
+8613533978874
Backup
Wenxiong Xu, Doctor
xuwenx@mail.sysu.edu.cn
+8613760783281
Time Frame
Start Date: 2024-09-27
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 60
Treatments
Experimental: Double plasma cytokine adsorption system with sequential low-dose plasma exchange
30 patients in this group will receive treatment of double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) and comprehensive internal medical treatment.
Active_comparator: Plasma exchange
30 patients in this group will receive treatment of plasma exchange(PE) and comprehensive internal medical treatment.
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov