Efficacy of Adaptive Blood Purification for Septic Shock (EABPSS): protocol for a randomised, multicentre, parallel...

Area of Science:

• Critical Care Medicine
• Nephrology
• Immunology

Background:

• Septic shock carries a high mortality rate, with limited evidence on extracorporeal blood purification (EBP) efficacy.
• Adaptive blood purification (ABP) is a novel strategy to potentially improve outcomes in septic shock.
• The Efficacy of Adaptive Blood Purification for Septic Shock (EABPSS) study aims to address this evidence gap.

Purpose of the Study:

• To evaluate the efficacy of adaptive blood purification (ABP) in reducing 90-day all-cause mortality in patients with septic shock.
• To assess the impact of ABP on serum cytokine levels, including TNF-α, IL-4, IL-6, IL-8, IL-10, and HMGB1.
• To determine the effect of ABP on the Sequential Organ Failure Assessment (SOFA) score and 30-day mortality.

Main Methods:

• A multicentre, open-label, randomised controlled trial (NCT06692036) involving 276 patients with septic shock.
• Patients are randomised 1:1 to receive either standard care or two 6-hour sessions of ABP within 24 hours.
• ABP involves plasmafiltration-adsorption (PFAD) alone or combined with renal replacement therapy (RRT) based on patient criteria.

Main Results:

• Primary endpoint is 90-day all-cause mortality.
• Secondary endpoints include changes in serum cytokine levels, SOFA score improvement by day 7, and 30-day mortality.
• Data collection and analysis are ongoing.

Conclusions:

• The EABPSS study will provide crucial evidence on the clinical benefit of ABP in septic shock.
• Findings are expected to inform clinical practice guidelines for managing septic shock.
• Dissemination will occur through peer-reviewed publications and conference presentations.