Adaptive Blood Purification for the Treatment of Patients With Septic Shock

Not Applicable

• Conditions: Septic Shock

• Registration Number: NCT06692036
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Study Start: 2025-01-01
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 276

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Declining proportion of serum cytokines	From enrollment to the end of first 24 hours.	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).
Improvement of SOFA score	The follow-up time ends on the 7th day after patient enrollment.	Improvement of sequential organ failure assessment score (SOFA) on the 7th day after enrollment.
All-cause mortality at day 30	The follow-up time ends on the 30th day after patient enrollment.	30-day all-cause mortality rate after enrollment.
Duration of stay	The follow-up time ends on the 90th day after patient enrollment.	The duration of stay in the intensive care unit and in the hospital.
Mortality rate	The follow-up time ends on the 90th day after patient enrollment.	The mortality rate within the intensive care unit and the hospital.
Requirement of RRT	The follow-up time ends on the 90th day after patient enrollment.	The requirement of renal replacement therapy (RRT) at both day 30 and day 90 after enrollment.

Trial Locations

Locations (1)

Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China