Status:
RECRUITING
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Acute-On-Chronic Liver Failure
Sepsis
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years.
- Total bilirubin (TBIL) \> 12 mg/dL, 3.5\>INR ≥ 1.5.
- Meets the diagnostic criteria for sepsis 3.0: confirmed or suspected infection with an increase in SOFA score by ≥ 2 points.
- High inflammatory state: IL-6 \> 80 pg/ml.
- Onset of sepsis within the past 72 hours.
Exclusion
- Presence of genetic metabolic liver disease.
- Patients with liver malignancies or other concurrent cancers.
- Pregnancy or lactation.
- Patients with HIV infection or other immunodeficiency diseases.
- Patients with autoimmune diseases, recent cardiovascular events leading to unstable infarction, or a history of organ transplantation.
- 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.
- Platelet count \< 50×10⁹/L, severe coagulopathy, or active bleeding.
- Allergic reactions to extracorporeal circulation, hemoperfusion substances, or history of severe allergies.
- Inability to comply with study protocols or refusal to sign the informed consent form.
- Inability to attend regular follow-up visits according to the study schedule.
- Any other conditions that, in the investigator's judgment, make the patient unsuitable for inclusion in the study.
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06562803
Start Date
September 27 2024
End Date
October 31 2026
Last Update
December 17 2025
Active Locations (1)
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1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630