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The EUPHAS Randomized Controlled Trial

Dinna N. Cruz, MD, MPH; Massimo Antonelli, MD; Roberto Fumagalli, MD; Francesca Foltran, MD; Nicola Brienza, MD, PhD; Abele Donati, MD; Vincenzo Malcangi, MD; Flavia Petrini, MD; Giada Volta, MD; Franco M. Bobbio Pallavicini, MD; Federica Rottoli, MD; Francesco Giunta, MD; Claudio Ronco, MD

JAMA. 2009;301(23):2445-2452.

Context  Polymyxin B fiber column is a medical device designed to reduce blood endotoxin levels in sepsis. Gram-negative–induced abdominal sepsis is likely associated with high circulating endotoxin. Reducing circulating endotoxin levels with polymyxin B hemoperfusion could potentially improve patient clinical outcomes.

Objective  To determine whether polymyxin B hemoperfusion added to conventional medical therapy improves clinical outcomes (mean arterial pressure [MAP], vasopressor requirement, oxygenation, organ dysfunction) and mortality compared with conventional therapy alone.

Design, Setting, and Patients  A prospective, multicenter, randomized controlled trial (Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis [EUPHAS]) conducted at 10 Italian tertiary care intensive care units between December 2004 and December 2007. Sixty-four patients were enrolled with severe sepsis or septic shock who underwent emergency surgery for intra-abdominal infection.

Intervention  Patients were randomized to either conventional therapy (n=30) or conventional therapy plus 2 sessions of polymyxin B hemoperfusion (n=34).

Main Outcome Measures  Primary outcome was change in MAP and vasopressor requirement, and secondary outcomes were PaO₂/FIO₂ (fraction of inspired oxygen) ratio, change in organ dysfunction measured using Sequential Organ Failure Assessment (SOFA) scores, and 28-day mortality.

Results  MAP increased (76 to 84 mm Hg; P = .001) and vasopressor requirement decreased (inotropic score, 29.9 to 6.8; P < .001) at 72 hours in the polymyxin B group but not in the conventional therapy group (MAP, 74 to 77 mm Hg; P = .37; inotropic score, 28.6 to 22.4; P = .14). The PaO₂/FIO₂ ratio increased slightly (235 to 264; P = .049) in the polymyxin B group but not in the conventional therapy group (217 to 228; P = .79). SOFA scores improved in the polymyxin B group but not in the conventional therapy group (change in SOFA, –3.4 vs –0.1; P < .001), and 28-day mortality was 32% (11/34 patients) in the polymyxin B group and 53% (16/30 patients) in the conventional therapy group (unadjusted hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.20-0.94; adjusted HR, 0.36; 95% CI, 0.16-0.80).

Conclusion  In this preliminary study, polymyxin B hemoperfusion added to conventional therapy significantly improved hemodynamics and organ dysfunction and reduced 28-day mortality in a targeted population with severe sepsis and/or septic shock from intra-abdominal gram-negative infections.

Trial Registration  clinicaltrials.gov Identifier: NCT00629382

Author Affiliations: Department of Nephrology, Dialysis, and Transplantation, St Bortolo Hospital and International Renal Research Institute Vicenza, Vicenza (Drs Cruz and Ronco); Department of Anesthesiology and Intensive Care, Policlinico Gemelli, Catholic University of Sacred Heart, Rome (Dr Antonelli); Department of Anesthesiology and Intensive Care I, Milano Bicocca University, St Gerardo dei Tintori Hospital, Monza (Dr Fumagalli); Department of Surgery, University of Pisa, Pisa (Drs Foltran and Giunta); Department of Emergency and Organ Transplantation, Anesthesia and Intensive Care Unit, University of Bari, Bari (Drs Brienza and Malcangi); Department of Neuroscience, Anesthesia, and Intensive Care, Polytechnical University of Marche, Ancona (Dr Donati); Department of Anesthesia, Intensive Care, and Emergency, University of Chieti-Pescara, Chieti (Dr Petrini); Department of Anesthesiology and Intensive Care, Policlinico S. Orsola-Malpighi Hospital, Bologna (Dr Volta); Department of Intensive Care, S. Martino University Hospital, Genova (Dr Bobbio Pallavicini); and Department of Anesthesiology and Intensive Care, Riuniti Hospital, Bergamo (Dr Rottoli), Italy.

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