Efficacy of Adaptive Blood Purification for Septic Shock (EABPSS): protocol for a randomised, multicentre, parallel controlled study
Abstract
Introduction: There is a lack of evidence on 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.
Methods and analysis: In this multicentre, open-label, randomised 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 enrolment, based on standard care. ABP is a novel, adaptive EBP strategy proposed by our research team. Specifically, for patients with septic shock who do not require renal replacement therapy (RRT), plasmafiltration-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 enrolment. Secondary endpoints of the study include the declining proportion of serum cytokines such as tumour necrosis factor-α (TNF-α), IL-4, IL-6, IL-8, IL-10 and high-mobility group box 1 within 24…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 276 participants or records.
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