Adaptive Blood Purification for the Treatment of Patients With Septic Shock

Adaptive Blood Purification for the Treatment of Patients With Septic Shock: a Multicenter, Open-label, Randomized, Parallel Controlled Study

There is a lack of evidence in the efficacy of extracorporeal blood purification (EBP) to reduce the mortality rate in septic shock. We have designed the EABPSS (Efficacy of Adaptive Blood Purification for Septic Shock) study to confirm whether adaptive blood purification (ABP) intervention could confer a clinical benefit. In this multicenter, open-label, randomized controlled trial, We are recruiting a total of 276 patients with septic shock. Eligible patients who provide informed consent will be randomly assigned in a 1:1 ratio to either the control group or the intervention group. Patients in the control group will receive standard care according to the Surviving Sepsis Guidelines. Patients in the intervention group will receive two 6-hour sessions of ABP treatment within 24 hours of enrollment, based on standard care. ABP is a novel, adaptive EBP strategy proposed by our research team, specifically, for patients with septic shock do not require renal replacement therapy (RRT), plasma filtration-adsorption (PFAD) will be used alone, and for patients with septic shock and acute kidney injury meeting RRT indications, a combination of PFAD-RRT will be employed. The primary endpoint of this study is all-cause mortality at 90 days after enrollment. Secondary endpoints of the study include the declining proportion of serum cytokines such as TNF-α, IL-4, IL-6, IL-8, IL-10, and HMGB1 within 24 hours after enrollment. Additionally, the study will evaluate the improvement of Sequential Organ Failure Assessment score on day 7 post-enrollment, as well as the 30-day mortality rate.

Study Overview

• Status: Enrolling by invitation
• Conditions: Septic Shock
• Intervention / Treatment: Other: Adaptive Blood Purification (ABP)

• Study Type: Interventional
• Enrollment (Estimated): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100020
      • Beijing Chao Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients admitted to intensive care unit (ICU), 18 years old ≤ age ≤ 82 years old;
2. Meeting the diagnostic criteria for septic shock (Sepsis 3.0), and the onset time of septic shock ≤ 24 hours;
3. Systemic inflammatory response syndrome (SIRS) ≥ 3 points;
4. Sequential organ failure assessment (SOFA) ≥ 6 points;
5. Voluntarily sign the informed consent form before the trial, and agree to participate in all visits, examinations, and treatments according to the requirements of the research plan.

Exclusion Criteria:

1. Patients who have received blood purification treatment within 1 week for any reason;
2. Patients with congenital or acquired immunodeficiency diseases, or those who have received organ transplantation;
3. Patients who have received immunosuppressive drugs (mycophenolate, cyclophosphamide, FK506, etc.) within 28 days before enrollment;
4. Patients who received continuous treatment (≥ 3 days) with more than 10 mg/day of prednisolone (or other hormones at equivalent doses) within 28 days before enrollment;
5. Patients with active bleeding (requiring blood transfusion > 3 units in the past 24 hours);
6. Patients with malignant tumors, those who cannot remove the lesions (such as surgical patients who cannot undergo surgical treatment);
7. End-stage organ failure (end-stage pulmonary heart disease, brain death, chronic liver disease combined with hepatic encephalopathy);
8. Platelet count < 30×10^9/L or neutrophil count < 0.5×10^9/L;
9. Patients who require supportive treatment due to acute pulmonary embolism or severe congestive heart failure;
10. The mean arterial blood pressure (MAP) cannot be maintained ≥ 65 mmHg after receiving vasoactive drugs and fluid resuscitation treatment;
11. Patients who have participated or participated in another clinical study within 28 days before enrollment;
12. Patients who are allergic to extracorporeal circulation materials, perfusion device materials or have a history of other severe allergies, or those who have heparin-associated thrombocytopenia;
13. Patients who are inappropriate for participating, such as pregnant or lactating women, patients with severe mental and neurological diseases, and those with a history of alcoholism that cannot be terminated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (standard treatment); Patients in the control group received standard treatment by the "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Experimental: Intervention group (standard treatment + ABP); Intervention Type: Patients in the intervention group, based on standard treatment, received two 6-hour adaptive blood purification (ABP) treatments within 24 hours after enrollment, that is, patients did not indicate renal replacement therapy (RRT), only plasma filtration-adsorption (PFAD) therapy is used to adsorb inflammatory factors; for patients with acute kidney injury (AKI) and meeting RRT indications, PFAD-RRT treatment is used.	Other: Adaptive Blood Purification (ABP); Patients in the intervention group, based on standard treatment, received two 6-hour adaptive blood purification (ABP) treatments within 24 hours after enrollment, that is, patients did not indicate renal replacement therapy (RRT), only coupled plasma filtration-adsorption (PFAD) therapy is used to adsorb inflammatory factors; for patients with acute kidney injury (AKI) and meeting RRT indications, PFAD-RRT treatment is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at day 90	The primary endpoint is all-cause mortality at day 90 after enrollment.	The follow-up time ends on the 90th day after patient enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Declining proportion of serum cytokines	The declining proportion (DP %) of serum cytokines such as TNF-α, IL-4, IL-6, IL-8, IL-10, and HMGB1 within 24 hours after enrollment (DP % = (CytokineH0 - CytokineH24)/CytokineH0 ), H0 is the serum cytokine level measured at the time of enrollment; H24 is the serum cytokine level measured at 24h after enrollment).	From enrollment to the end of first 24 hours.
Improvement of SOFA score	Improvement of sequential organ failure assessment score (SOFA) on the 7th day after enrollment.	The follow-up time ends on the 7th day after patient enrollment.
All-cause mortality at day 30	30-day all-cause mortality rate after enrollment.	The follow-up time ends on the 30th day after patient enrollment.
Duration of stay	The duration of stay in the intensive care unit and in the hospital.	The follow-up time ends on the 90th day after patient enrollment.
Mortality rate	The mortality rate within the intensive care unit and the hospital.	The follow-up time ends on the 90th day after patient enrollment.
Requirement of RRT	The requirement of renal replacement therapy (RRT) at both day 30 and day 90 after enrollment.	The follow-up time ends on the 90th day after patient enrollment.

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Collaborators: Peking University First Hospital; Chinese PLA General Hospital; Beijing Hospital; China-Japan Friendship Hospital; Beijing Jishuitan Hospital; Air Force Medical Center of PLA

Publications and helpful links

General Publications

• Jia H, Li X, Zheng Y, Cui N, Ronco C, Li W. Efficacy of Adaptive Blood Purification for Septic Shock (EABPSS): protocol for a randomised, multicentre, parallel controlled study. BMJ Open. 2025 Oct 20;15(10):e107311. doi: 10.1136/bmjopen-2025-107311.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: Capital'sFunds2024-1-2031; 2024-1-2031 (Other Grant/Funding Number: Capital's Funds for Health Improvement and Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: EABPSS (Efficacy of Adaptive Blood Purification for Septic Shock) study aims to confirm whether adaptive blood purification (ABP) intervention could confer a clinical benefit.
• IPD Sharing Time Frame: 2026.1.1-2028.12.31
• IPD Sharing Access Criteria: Researchers who focus on extracorporeal blood purification for the treatment of septic shock will be able to access the IPD and supporting information. And they will access the relevant data needed in the Case Report Form according to the visitor's research plan. By sending email to the research group, fill in the plan of the research scheme, and the feasibility of the scheme will be evaluated by the research group. If the evaluation is passed, the researcher will be granted access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No