Protocol for a Randomized, Open-Label, Multicenter, Parallel-Controlled Study Evaluating Modified Double Filtration Plasmapheresis for the Treatment of Septic Shock.

Abstract

Introduction: Septic shock (SS) is defined as sepsis-induced hypotension persisting despite adequate fluid resuscitation. Modified double filtration plasmapheresis (M-DFPP) is a promising therapeutic approach designed to selectively remove small-to-medium molecular weight inflammatory mediators while preserving essential plasma proteins, potentially restoring immune balance and stabilizing hemodynamics in patients with SS.

Methods: Eligible patients diagnosed with SS will be enrolled in this randomized controlled trial. Inclusion criteria include completion of early goal-directed therapy resuscitation standards within 12 h following admission to the intensive care unit and norepinephrine administration exceeding 0.5 µg/min/kg. The intervention group will receive treatment using the M-DFPP multivariate model. The primary endpoint is all-cause mortality at 28 days. Secondary endpoints will assess the efficacy of M-DFPP in reducing inflammatory mediators, evaluate changes in vasoactive drug requirements on the third day post-enrollment, and quantify improvement in organ dysfunction.

Conclusion: Validation through well-designed, large-scale randomized controlled trials is required to clarify the optimal patient selection criteria, treatment timing, frequency, and standardized protocols for M-DFPP. This is an experimental protocol of a randomized, open-label, multicenter, parallel-controlled trial aiming to evaluate whether M-DFPP can improve survival rates in patients with SS.