Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis (NCT06562803) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis
China192 participantsStarted 2024-09-27
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✕. 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).
What they're measuring
1
Mortality rate
Timeframe: 4 weeks
Trial details
NCT IDNCT06562803
SponsorThird Affiliated Hospital, Sun Yat-Sen University
✕. 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.