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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
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.
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
All-cause mortality at day 90
The primary endpoint is all-cause mortality at day 90 after enrollment.
Time frame: The follow-up time ends on the 90th day after patient enrollment.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The follow-up time ends on the 90th day after patient enrollment.
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