Clinical trial NCT06562803: Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With HBV-ACLF and Sepsis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Sepsis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: Inclusion Criteria:

1. Age between 18 and 65 years.
2. Total bilirubin (TBIL) \> 12 mg/dL, 3\>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 \> 100 pg/ml.
5. Persistent HBsAg or HBV DNA positivity for more than 6 months.
6. Onset of sepsis within the past 72 hours.

Exclusion Criteria:

1. Presence of other causes of chronic liver disease, such as infection with other hepatotropic viruses, alcoholic liver disease, autoimmune liver disease, or 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.

Primary outcomes:
measure: Mortality rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Mortality rate
timeFrame: 12 weeks
measure: Changes in Acute Physiology and Chronic Health Evaluation II score from baseline
timeFrame: 1, 2, 3, and 4 weeks
measure: Changes in sequential organ failure assessment score from baseline
timeFrame: 1, 2, 3, and 4 weeks
measure: Changes in vasoactive-inotropic score from baseline
timeFrame: 1, 2, 3, and 4 weeks
measure: Changes in Model for End-Stage Liver Disease score from baseline
timeFrame: 1, 2, 3, and 4 weeks
measure: Changes in COSSH-ACLF II score from baseline
timeFrame: 1, 2, 3, and 4 weeks
measure: Adsorption rates of various cytokines
timeFrame: Day2, Day4
measure: Adsorption rates of lactate
timeFrame: Day2, Day4
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: