Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With HBV-ACLF and Sepsis

Not Applicable

Recruiting

• Conditions: Sepsis; Acute-On-Chronic Liver Failure
• Interventions: Device: double plasma cytokine adsorption system with sequential low-dose plasma exchange; Other: plasma exchange

• Registration Number: NCT06562803
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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 hepatitis B-related acute-on-chronic liver failure (HBV-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 HBV-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

Not available

Study Timeline

• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-17
• Study First Posted: 2024-08-20
• Study Start: 2024-09-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-09-01
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age between 18 and 65 years.
2. Total bilirubin (TBIL) > 12 mg/dL, 3>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 > 100 pg/ml.
5. Persistent HBsAg or HBV DNA positivity for more than 6 months.
6. Onset of sepsis within the past 72 hours.

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Exclusion Criteria

1. Presence of other causes of chronic liver disease, such as infection with other hepatotropic viruses, alcoholic liver disease, autoimmune liver disease, or genetic metabolic liver disease.

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double plasma cytokine adsorption system with sequential low-dose plasma exchange	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.
Plasma exchange	plasma exchange	30 patients in this group will receive treatment of plasma exchange(PE) and comprehensive internal medical treatment.

Primary Outcome Measures

Name	Time	Method
Mortality rate	4 weeks	4-week mortality rate

Secondary Outcome Measures

Name	Time	Method
Mortality rate	12 weeks	12-week Mortality rate
Changes in vasoactive-inotropic score from baseline	1, 2, 3, and 4 weeks	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.
Changes in Model for End-Stage Liver Disease score from baseline	1, 2, 3, and 4 weeks	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 ).
Changes in Acute Physiology and Chronic Health Evaluation II score from baseline	1, 2, 3, and 4 weeks	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.
Changes in COSSH-ACLF II score from baseline	1, 2, 3, and 4 weeks	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 ).
Adsorption rates of various cytokines	Day2, Day4	Adsorption rates of various cytokines (including pro-inflammatory and anti-inflammatory cytokines) after each treatment
Adsorption rates of lactate	Day2, Day4	Adsorption rates of lactate after each treatment
Changes in sequential organ failure assessment score from baseline	1, 2, 3, and 4 weeks	The theoretical value range of sequential organ failure assessment（SOFA） score is 6-24. The higher the score, the worse the prognosis.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China