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Direct hemoperfusion with polymyxin B immobilized fiber for abdominal sepsis in Europe
Koichi Sato1, Hiroshi Maekawa, Mutsumi Sakurada
1Department of Surgery, Juntendo Shizuoka Hospital, Juntendo University School of Medicine, 1129 Izunokuni, Shizuoka, 410-2295, Japan.
Abstract:
Since direct hemoperfusion with polymyxin B immobilized fiber (PMX-DHP) received its product certification for use in Europe in 1998, several prospective randomized controlled trials (RCTs) have been conducted in European countries. The first RCT, performed in six European academic medical centers in 2005, concluded that PMX-DHP is associated with improved hemodynamic status and cardiac function. Subsequently, a meta-analysis of PMX-DHP was presented in Italy in 2007. This systematic review found positive effects of PMX-DHP on mean arterial pressure and dopamine/ dobutamine use, PaO2/FiO2 ratio, endotoxin removal, and mortality. However, like most trials on extracorporeal therapies, none of the studies was double-blinded. The EUPHAS study, a multicenter RCT performed in ten Italian intensive care units in 2009, found that PMX-DHP improved 28-day survival, blood pressure, vasopressor requirement, and degree of organ failure. However, investigators in Belgium and Canada pointed out that there was no statistical difference in 28-day survival. Two more RCTs, the ABDO-MIX and EUPHRATES studies, the primary end points of which are 28-day mortality, were started in Europe and the United States at the end of 2010. We are hoping that these RCTs will resolve this issue.
Insights
Direct hemoperfusion with polymyxin B immobilized fiber (PMX-DHP) shows promise in improving hemodynamic status and reducing mortality in sepsis patients. Further randomized controlled trials are ongoing to confirm these beneficial effects in intensive care settings.
Area of Science:
- Critical Care Medicine
- Nephrology
- Sepsis Pathophysiology
Background:
- Polymyxin B immobilized fiber direct hemoperfusion (PMX-DHP) is an extracorporeal therapy.
- PMX-DHP received European certification in 1998 for treating sepsis.
- Several randomized controlled trials (RCTs) have investigated its efficacy.
Purpose of the Study:
- To review the existing evidence from RCTs on PMX-DHP.
- To assess the impact of PMX-DHP on hemodynamic status, organ function, and mortality in sepsis.
- To identify areas of controversy and the need for further research.
Main Methods:
- Review of prospective randomized controlled trials (RCTs) conducted in Europe and North America.
- Analysis of meta-analyses and systematic reviews evaluating PMX-DHP.
- Examination of clinical outcomes including hemodynamic parameters, oxygenation, vasopressor use, and mortality.
Main Results:
- Early RCTs and meta-analyses suggested improved hemodynamic status, reduced vasopressor use, better oxygenation (PaO2/FiO2 ratio), and endotoxin removal.
- The EUPHAS study indicated improved 28-day survival, blood pressure, and organ failure scores.
- Some studies reported no statistically significant difference in 28-day survival, highlighting a need for further investigation.
Conclusions:
- PMX-DHP has demonstrated potential benefits in improving sepsis management, particularly in hemodynamic support and organ function.
- Contradictory findings regarding mortality benefits necessitate ongoing large-scale RCTs like ABDO-MIX and EUPHRATES.
- Further high-quality evidence is crucial to definitively establish the role of PMX-DHP in sepsis treatment.
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