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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство double plasma cytokine adsorption system with sequential low-dose plasma exchange
  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
• Другое plasma exchange
  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.

Первичные конечные точки

• Mortality rate [Срок оценки: 4 weeks]

Вторичные конечные точки (8)

• Mortality rate [Срок оценки: 12 weeks]
• Changes in Acute Physiology and Chronic Health Evaluation II score from baseline [Срок оценки: 1, 2, 3, and 4 weeks]
• Changes in sequential organ failure assessment score from baseline [Срок оценки: 1, 2, 3, and 4 weeks]
• Changes in vasoactive-inotropic score from baseline [Срок оценки: 1, 2, 3, and 4 weeks]
• Changes in Model for End-Stage Liver Disease score from baseline [Срок оценки: 1, 2, 3, and 4 weeks]
• Changes in COSSH-ACLF II score from baseline [Срок оценки: 1, 2, 3, and 4 weeks]
• Adsorption rates of various cytokines [Срок оценки: Day1]
• Adsorption rates of lactate [Срок оценки: Day1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06562803 · PL18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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