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Updated: Nov 15, 2025

Endotoxin Activity Assay for the Detection of Whole Blood Endotoxemia in Critically Ill Patients
Published on: June 24, 2019
Therapeutic Rationale for Endotoxin Removal with Polymyxin B Immobilized Fiber Column (PMX) for Septic Shock
Hisataka Shoji1, Steven M Opal2
1Division of Emergency and Critical Care Medicine, Toray Medical Co., Ltd, Tokyo 103-0023, Japan.
Abstract:
Endotoxin removal therapy with polymyxin B immobilized fiber column (PMX) has been clinically applied for sepsis and septic shock patients since 1994. The effectiveness and usefulness of this therapy have been demonstrated for more than a quarter of a century. However, a documented survival benefit has not yet been demonstrable in a large, multicenter, randomized and controlled trial. Following the findings derived from a large sepsis clinical trial with PMX in North America, a new trial is ongoing to determine if PMX has a long-term survival benefit when administered to septic patients. Another approach to support a survival benefit from intervention with PMX is to utilize a detailed analysis available from a large clinical data base. The endotoxin adsorption capacity of PMX columns in vitro and the effectiveness of PMX columns can be further demonstrable in animal models. The capability of PMX and details of its mechanism of action to intervene in the sepsis cascade and impede organ dysfunction in septic patients is not fully understood. The surface antigen expression in monocytes and neutrophils are improved after PMX therapy. Immunomodulatory effects as a result of endotoxin removal and/or other mechanisms of action have been suggested. These effects and other potential immune effects may explain some of the improved effects upon organ dysfunction of sepsis and septic shock patients. Endotoxemia may be involved in the pathophysiology of other diseases than sepsis. A rapid diagnostic method to detect and target endotoxemia could allow us to practice precision medicine and expand the clinical indications of endotoxin removal therapy.
Insights
Polymyxin B (PMX) therapy removes endotoxins in sepsis patients, but large trials are needed to confirm survival benefits. Ongoing research and data analysis aim to clarify PMX
Area of Science:
- Critical care medicine
- Immunology
- Biomaterials
Background:
- Polymyxin B immobilized fiber (PMX) column therapy has been used for sepsis and septic shock since 1994.
- Despite extensive clinical application, a large, multicenter, randomized controlled trial has not yet demonstrated a definitive survival benefit.
- The precise mechanisms by which PMX intervenes in the sepsis cascade and mitigates organ dysfunction remain incompletely understood.
Purpose of the Study:
- To evaluate the ongoing and potential long-term survival benefits of PMX therapy in septic patients.
- To further elucidate the immunomodulatory effects and mechanisms of action of PMX therapy.
- To explore the potential for expanding clinical indications of endotoxin removal therapy through rapid diagnostics.
Main Methods:
- Analysis of findings from a large sepsis clinical trial conducted in North America.
- Ongoing large, multicenter, randomized controlled trial to assess long-term survival benefit.
- In vitro assessment of endotoxin adsorption capacity and in vivo studies in animal models.
- Detailed analysis of large clinical databases to support survival benefit claims.
Main Results:
- PMX therapy has demonstrated effectiveness and usefulness for over 25 years in clinical practice.
- Surface antigen expression on monocytes and neutrophils shows improvement post-PMX therapy.
- Immunomodulatory effects, potentially beyond endotoxin removal, are suggested as contributing to improved organ function.
Conclusions:
- Further research, including ongoing trials and data analysis, is crucial to definitively establish the survival benefit of PMX therapy.
- Understanding the detailed mechanisms of PMX is key to optimizing its application in sepsis and potentially other endotoxemia-related diseases.
- Developing rapid diagnostics for endotoxemia could enable precision medicine and broaden the use of endotoxin removal therapies.
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