Efficacy and safety of double plasma cytokine adsorption system with sequential low-volume plasma exchange in treating acute-on-chronic liver failure complicated by sepsis: protocol for a multicentre randomised controlled clinical trial
- 1Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
- 2Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
Abstract
Introduction Acute-on-chronic liver failure (ACLF) and sepsis are both life-threatening clinical syndromes that frequently coexist. Patients with ACLF complicated by sepsis experience significantly higher mortality rates, yet therapeutic options remain limited. This randomised controlled trial aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-volume plasma exchange (DPCAS+LPE) in patients with ACLF complicated by sepsis.Methods and analysis This is a multicentre, prospective, open-label, parallel-group, randomised clinical trial. A total of 192 patients with ACLF complicated by sepsis will be recruited from five hospitals in China. Participants will be randomly assigned (1:1) to either the intervention group or the control group. Both groups will receive standard medical treatment and three sessions of artificial liver support system (ALSS) therapy administered every other day. The intervention group will receive two sessions of DPCAS+LPE followed by one session of plasma exchange (PE), while the control group will receive three sessions of PE. The primary outcome is the 4-week mortality rate. Secondary outcomes include the 12-week mortality rate; longitudinal changes in Acute Physiology and Chronic Health Evaluation II, Sequential Organ Failure Assessment, Model for End-Stage Liver Disease and Chinese Group on the Study of Severe Hepatitis B-associated ACLF II scores; and the Vasoactive-Inotropic Score at weeks 1, 2, 3 and 4 post baseline. Furthermore, the clearance rates of various cytokines and lactate will be measured after the first ALSS session. Safety will be assessed by documenting and managing all adverse events throughout the study.Ethics and dissemination This study has been approved by the medical ethics committee of the Third Affiliated Hospital of Sun Yat-sen University (approval no: II2024-204-06). The trial will be conducted in strict accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentations at national and international hepatology or critical care conferences and through publication in peer-reviewed journals. The findings will also be shared with relevant clinical stakeholders to inform future treatment guidelines for ACLF and sepsis.Trial registration number NCT06562803.
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BibTeX
@article{chen2026efficacy,
title = {{Efficacy and safety of double plasma cytokine adsorption system with sequential low-volume plasma exchange in treating acute-on-chronic liver failure complicated by sepsis: protocol for a multicentre randomised controlled clinical trial}},
author = {Jia Chen and Yihua Pang and Lina Wu and Lili Li and Lihua Zheng and Shan Ouyang and Xiyao Chen and Yuankai Wu and Wenxiong Xu and Liang Peng},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2025-115807},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-115807},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Efficacy and safety of double plasma cytokine adsorption system with sequential low-volume plasma exchange in treating acute-on-chronic liver failure complicated by sepsis: protocol for a multicentre randomised controlled clinical trial
AU - Jia Chen
AU - Yihua Pang
AU - Lina Wu
AU - Lili Li
AU - Lihua Zheng
AU - Shan Ouyang
AU - Xiyao Chen
AU - Yuankai Wu
AU - Wenxiong Xu
AU - Liang Peng
PY - 2026
DA - 2026/10/23
JO - BMJ Open
DO - 10.1136/bmjopen-2025-115807
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-115807
AB - Introduction Acute-on-chronic liver failure (ACLF) and sepsis are both life-threatening clinical syndromes that frequently coexist. Patients with ACLF complicated by sepsis experience significantly higher mortality rates, yet therapeutic options remain limited. This randomised controlled trial aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-volume plasma exchange (DPCAS+LPE) in patients with ACLF complicated by sepsis.Methods and analysis This is a multicentre, prospective, open-label, parallel-group, randomised clinical trial. A total of 192 patients with ACLF complicated by sepsis will be recruited from five hospitals in China. Participants will be randomly assigned (1:1) to either the intervention group or the control group. Both groups will receive standard medical treatment and three sessions of artificial liver support system (ALSS) therapy administered every other day. The intervention group will receive two sessions of DPCAS+LPE followed by one session of plasma exchange (PE), while the control group will receive three sessions of PE. The primary outcome is the 4-week mortality rate. Secondary outcomes include the 12-week mortality rate; longitudinal changes in Acute Physiology and Chronic Health Evaluation II, Sequential Organ Failure Assessment, Model for End-Stage Liver Disease and Chinese Group on the Study of Severe Hepatitis B-associated ACLF II scores; and the Vasoactive-Inotropic Score at weeks 1, 2, 3 and 4 post baseline. Furthermore, the clearance rates of various cytokines and lactate will be measured after the first ALSS session. Safety will be assessed by documenting and managing all adverse events throughout the study.Ethics and dissemination This study has been approved by the medical ethics committee of the Third Affiliated Hospital of Sun Yat-sen University (approval no: II2024-204-06). The trial will be conducted in strict accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentations at national and international hepatology or critical care conferences and through publication in peer-reviewed journals. The findings will also be shared with relevant clinical stakeholders to inform future treatment guidelines for ACLF and sepsis.Trial registration number NCT06562803.
SN - 2044-6055
SN - 2044-6055
ER -