Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis
NCT ID: NCT06562803
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-27
2026-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Double plasma cytokine adsorption system with sequential low-dose plasma exchange
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.
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. Artificial liver therapy was initiated for both groups on the day of enrollment, with treatments 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 cytokine adsorption column (CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) and a bilirubin adsorption device (BS330,Jafron Biomedical Co., Ltd., Zhuhai, China) on the same treatment circuit. DPCAS treatment was performed first, with an adsorption volume of 4500ml to 5000ml over 2 to 3 hours, followed by plasma exchange (PE), with 1000ml of plasma and 500ml of 4% albumin being infused. The third treatment was plasma exchange, with the same dosing as in the control group.
Plasma exchange
30 patients in this group will receive treatment of plasma exchange(PE) and comprehensive internal medical treatment.
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.
Interventions
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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. Artificial liver therapy was initiated for both groups on the day of enrollment, with treatments 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 cytokine adsorption column (CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) and a bilirubin adsorption device (BS330,Jafron Biomedical Co., Ltd., Zhuhai, China) on the same treatment circuit. DPCAS treatment was performed first, with an adsorption volume of 4500ml to 5000ml over 2 to 3 hours, followed by plasma exchange (PE), with 1000ml of plasma and 500ml of 4% albumin being infused. The third treatment was plasma exchange, with the same dosing as in the control group.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Liang Peng
Professor
Principal Investigators
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Liang Peng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PL18
Identifier Type: -
Identifier Source: org_study_id