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

Sun Yat-sen University

Status: Enrolling

Conditions: Acute-On-Chronic Liver Failure; Sepsis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06562803

PL18

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 65 years.
2. Total bilirubin (TBIL) > 12 mg/dL, 3.5>INR ≥ 1.5.
3. Meets the diagnostic criteria for sepsis 3.0: confirmed or suspected infection with an increase in SOFA score by ≥ 2 points.
4. High inflammatory state: IL-6 > 80 pg/ml.
5. Onset of sepsis within the past 72 hours.

Exclusion criteria

1. Presence of genetic metabolic liver disease.

2. Patients with liver malignancies or other concurrent cancers.

3. Pregnancy or lactation.

4. Patients with HIV infection or other immunodeficiency diseases.

5. Patients with autoimmune diseases, recent cardiovascular events leading to unstable infarction, or a history of organ transplantation.

6. 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 maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation, vasopressors, and steroid therapy.

7. Platelet count < 50×10⁹/L, severe coagulopathy, or active bleeding.

8. Allergic reactions to extracorporeal circulation, hemoperfusion substances, or history of severe allergies.

9. Inability to comply with study protocols or refusal to sign the informed consent form.

10. Inability to attend regular follow-up visits according to the study schedule.

11. Any other conditions that, in the investigator's judgment, make the patient unsuitable for inclusion in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Plasma exchange

Active Comparator group

Description:

30 patients in this group will receive treatment of plasma exchange(PE) and comprehensive internal medical treatment.

Treatment:

Other: plasma exchange