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

NCT06562803 | Recruiting

• 1 other identifier: PL18
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute-On-Chronic Liver Failure; Sepsis

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  4-week mortality rate

  4 weeks

Secondary Outcomes (8)

• Mortality rate

  12 weeks

• Changes in Acute Physiology and Chronic Health Evaluation II score from baseline

  1, 2, 3, and 4 weeks

• Changes in sequential organ failure assessment score from baseline

  1, 2, 3, and 4 weeks

• Changes in vasoactive-inotropic score from baseline

  1, 2, 3, and 4 weeks

• Changes in Model for End-Stage Liver Disease score from baseline

  1, 2, 3, and 4 weeks

Study Arms (2)

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

EXPERIMENTAL

96 patients in this group will receive standard medical treatment, double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) for two sessions, and plasma exchange(PE) for the third session.

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

Plasma exchange

ACTIVE COMPARATOR

96 patients in this group will receive standard medical treatment and plasma exchange(PE) for three sessions.

Other: plasma exchange

Interventions

plasma exchange OTHER

Based on comprehensive medical treatment, the control group received plasma exchange(PE) treatment, where whole blood was processed through a plasma separator (MICROPLAS MPS 07, BELLCO S.R.L., Italy), with a portion of the plasma discarded and replaced with 1000ml of plasma and 500ml of 4% albumin.Three sessions of plasma exchange (PE) performed every other day.

Plasma exchange

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

Both groups received comprehensive medical treatment, including antiviral therapy, anti-infection treatment, supportive care, symptomatic treatment, and prevention of complications. All patients will initiate ALSS within 48 hours of enrollment, with treatment administered every other day, for a total of three sessions. The experimental group： The first two sessions consisted of a double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE). This involved using a cytokine adsorption column (CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) and a bilirubin adsorption device (BS330,Jafron Biomedical Co., Ltd., Zhuhai, China) on the same treatment circuit. DPCAS treatment was performed first, with an adsorption volume of 4500ml to 5000ml over 2 to 3 hours, followed by plasma exchange (PE), with 1000ml of plasma and 500ml of 4% albumin being infused. The third treatment was plasma exchange, with the same dosing as in the control group.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years with a background of chronic liver disease, regardless of 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 a sequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) High inflammatory status: IL-6 \> 80 pg/ml.
• (6) Diagnosis of sepsis within the past 72 hours.

You may not qualify if:

• Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, 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 immunodeficiency diseases (including active hematological malignancies, congenital immunodeficiency syndromes, or those currently receiving high-dose systemic immunosuppressive therapy).
• Unstable phase of cerebrovascular events.
• History of organ transplantation.
• Patients with irreversible or terminal extrahepatic organ failure that precludes safe extracorporeal circulation or confounds the intervention: ①Terminal chronic obstructive pulmonary disease, terminal cor pulmonale, brain death, or persistent vegetative state, or Grade IV hepatic encephalopathy. ②Requirement for renal replacement therapy (RRT) at the time of screening/enrollment. ③Despite adequate fluid resuscitation, vasopressors, and steroid treatment, unable to maintain mean arterial pressure above 65 mmHg.
• Platelet count \< 50×10E9/L, severe coagulation disorders (INR\>3.5), or active bleeding.
• Known allergies to extracorporeal circulation, hemoperfusion, or other severe allergic history.
• Refusal by the patient or their legally authorized representative (LAR) to participate 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 patient unsuitable for enrollment.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Sepsis

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Liang Peng, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Peng, Doctor

CONTACT

+8613533978874; pliang@mail.sysu.edu.cn

Wenxiong Xu, Doctor

CONTACT

+8613760783281; xuwenx@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 20, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to pliang@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)