An interventional study of double plasma cytokine adsorption system with sequential low-dose plasma exchange and plasma exchange in Acute-On-Chronic Liver Failure and Sepsis, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.
This study's planned enrollment of 192 is above the median of 72 across 95 interventional studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(6) Diagnosis of sepsis within the past 72 hours.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
96 patients in this group will receive standard medical treatment, double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) for two sessions, and plasma exchange(PE) for the third session.
Device: double plasma cytokine adsorption system with sequential low-dose plasma exchange
96 patients in this group will receive standard medical treatment and plasma exchange(PE) for three sessions.
Other: 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 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.
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.
Mortality rate
4-week mortality rate
Time frame: 4 weeks
Mortality rate
12-week Mortality rate
Time frame: 12 weeks
Changes in Acute Physiology and Chronic Health Evaluation II score from baseline
The theoretical maximum value of Acute Physiology and Chronic Health Evaluation II score（APACHE II score） was 71 points. The higher the score, the higher the risk of death. Patients with more than 15 points were classified as severe, and patients with less than 15 points were classified as non-severe.
Time frame: 1, 2, 3, and 4 weeks
Changes in sequential organ failure assessment score from baseline
The theoretical value range of sequential organ failure assessment（SOFA） score is 6-24. The higher the score, the worse the prognosis.
Time frame: 1, 2, 3, and 4 weeks
Changes in vasoactive-inotropic score from baseline
Vasoactive-Inotropic Score ( VIS ) evaluates cardiac function and the intensity of vasoactive drug therapy in critically ill patients by quantifying the dose of vasoactive and inotropic drugs received by patients. VIS has no special value range. The higher the score, the higher the patient 's dependence on vasoactive drugs.
Time frame: 1, 2, 3, and 4 weeks
Changes in Model for End-Stage Liver Disease score from baseline
MELD score is now widely used in the prioritization of liver transplantation candidates in many countries. The score range is usually between 6 ( low risk ) and 40 ( high risk ).
Time frame: 1, 2, 3, and 4 weeks
Changes in COSSH-ACLF II score from baseline
COSSH-ACLF II is a prognostic scoring system for hepatitis B virus -related acute-on-chronic liver failure（HBV-ACLF）. COSSH-ACLF IIs can significantly divide ACLF patients into three risk groups based on two cutoff values of 7.4 and 8.4 : low-risk group ( \< 7.4 points ), medium-risk group ( 7.4-8.4 points ) and high-risk group ( ≥ 8.4 points ).
Time frame: 1, 2, 3, and 4 weeks
Adsorption rates of various cytokines
Adsorption rates of various cytokines (including pro-inflammatory and anti-inflammatory cytokines) after each treatment
Time frame: Day1
Adsorption rates of lactate
Adsorption rates of lactate after each treatment
Time frame: Day1
Plan to share: Yes — The study protocol, results and conclusions of this clinical trial will be published at academic conferences or in journals.
Supporting information: Study protocol, Clinical study report
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Proposals should be directed to pliang@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Oct 2027, 37 months after the start.
Of 32 interventional studies with no phase under Acute-On-Chronic Liver Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's planned 37 months is above that.
How these figures are worked out, and which studies are left out of them.
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Acute-On-Chronic Liver Failure →
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