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      Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial

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          Abstract

          Purpose

          To test whether the polymyxin B hemoperfusion (PMX HP) fiber column reduces mortality and organ failure in peritonitis-induced septic shock (SS) from abdominal infections.

          Method

          Prospective, multicenter, randomized controlled trial in 18 French intensive care units from October 2010 to March 2013, enrolling 243 patients with SS within 12 h after emergency surgery for peritonitis related to organ perforation. The PMX HP group received conventional therapy plus two sessions of PMX HP. Primary outcome was mortality on day 28; secondary outcomes were mortality on day 90 and a reduction in the severity of organ failures based on Sequential Organ Failure Assessment (SOFA) scores.

          Results

          Primary outcome: day 28 mortality in the PMX HP group ( n = 119) was 27.7 versus 19.5 % in the conventional group ( n = 113), p = 0.14 (OR 1.5872, 95 % CI 0.8583–2.935). Secondary endpoints: mortality rate at day 90 was 33.6 % in PMX-HP versus 24 % in conventional groups, p = 0.10 (OR 1.6128, 95 % CI 0.9067–2.8685); reduction in SOFA score from day 0 to day 7 was −5 (−11 to 6) in PMX-HP versus −5 (−11 to 9), p = 0.78. Comparable results were observed in the predefined subgroups (presence of comorbidity; adequacy of surgery, <2 sessions of hemoperfusion) and for SOFA reduction from day 0 to day 3.

          Conclusion

          This multicenter randomized controlled study demonstrated a non-significant increase in mortality and no improvement in organ failure with PMX HP treatment compared to conventional treatment of peritonitis-induced SS.

          Electronic supplementary material

          The online version of this article (doi:10.1007/s00134-015-3751-z) contains supplementary material, which is available to authorized users.

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          Most cited references 16

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          Hospital deaths in patients with sepsis from 2 independent cohorts.

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            High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial.

            Septic shock is a leading cause of death among critically ill patients, in particular when complicated by acute kidney injury (AKI). Small experimental and human clinical studies have suggested that high-volume haemofiltration (HVHF) may improve haemodynamic profile and mortality. We sought to determine the impact of HVHF on 28-day mortality in critically ill patients with septic shock and AKI. This was a prospective, randomized, open, multicentre clinical trial conducted at 18 intensive care units in France, Belgium and the Netherlands. A total of 140 critically ill patients with septic shock and AKI for less than 24 h were enrolled from October 2005 through March 2010. Patients were randomized to either HVHF at 70 mL/kg/h or standard-volume haemofiltration (SVHF) at 35 mL/kg/h, for a 96-h period. Primary endpoint was 28-day mortality. The trial was stopped prematurely after enrolment of 140 patients because of slow patient accrual and resources no longer being available. A total of 137 patients were analysed (two withdrew consent, one was excluded); 66 patients in the HVHF group and 71 in the SVHF group. Mortality at 28 days was lower than expected but not different between groups (HVHF 37.9 % vs. SVHF 40.8 %, log-rank test p = 0.94). There were no statistically significant differences in any of the secondary endpoints between treatment groups. In the IVOIRE trial, there was no evidence that HVHF at 70 mL/kg/h, when compared with contemporary SVHF at 35 mL/kg/h, leads to a reduction of 28-day mortality or contributes to early improvements in haemodynamic profile or organ function. HVHF, as applied in this trial, cannot be recommended for treatment of septic shock complicated by AKI.
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              Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review

              Introduction Severe sepsis and septic shock are common problems in the intensive care unit and carry a high mortality. Endotoxin, one of the principal components on the outer membrane of gram-negative bacteria, is considered important to their pathogenesis. Polymyxin B bound and immobilized to polystyrene fibers (PMX-F) is a medical device that aims to remove circulating endotoxin by adsorption, theoretically preventing the progression of the biological cascade of sepsis. We performed a systematic review to describe the effect in septic patients of direct hemoperfusion with PMX-F on outcomes of blood pressure, use of vasoactive drugs, oxygenation, and mortality reported in published studies. Methods We searched PubMed, the Cochrane Collaboration Database, and bibliographies of retrieved articles and consulted with experts to identify relevant studies. Prospective and retrospective observational studies, pre- and post-intervention design, and randomized controlled trials were included. Three authors reviewed all citations. We identified a total of 28 publications – 9 randomized controlled trials, 7 non-randomized parallel studies, and 12 pre-post design studies – that reported at least one of the specified outcome measures (pooled sample size, 1,425 patients: 978 PMX-F and 447 conventional medical therapy). Results Overall, mean arterial pressure (MAP) increased by 19 mm Hg (95% confidence interval [CI], 15 to 22 mm Hg; p < 0.001), representing a 26% mean increase in MAP (range, 14% to 42%), whereas dopamine/dobutamine dose decreased by 1.8 μg/kg per minute (95% CI, 0.4 to 3.3 μg/kg per minute; p = 0.01) after PMX-F. There was significant intertrial heterogeneity for these outcomes (p < 0.001), which became non-significant when analysis was stratified for baseline MAP. The mean arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio increased by 32 units (95% CI, 23 to 41 units; p < 0.001). PMX-F therapy was associated with significantly lower mortality risk (risk ratio, 0.53; 95% CI, 0.43 to 0.65). The trials assessed had suboptimal method quality. Conclusion Based on this critical review of the published literature, direct hemoperfusion with PMX-F appears to have favorable effects on MAP, dopamine use, PaO2/FiO2 ratio, and mortality. However, publication bias and lack of blinding need to be considered. These findings support the need for further rigorous study of this therapy.
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                Author and article information

                Contributors
                dpayen1234@orange.fr
                rene.robert@chu-poitiers.fr
                Journal
                Intensive Care Med
                Intensive Care Med
                Intensive Care Medicine
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0342-4642
                1432-1238
                11 April 2015
                11 April 2015
                2015
                : 41
                : 6
                : 975-984
                Affiliations
                [ ]Department of Anesthesia and Critical Care, SAMU, Lariboisière University Hospital, University Paris 7 Denis Diderot, Paris, France
                [ ]Paris Sorbone Cité and U 1160 INSERM, Paris, France
                [ ]Inserm Unit CIC 1402, La milèterie University Hospital, University Poitiers, Poitiers, France
                [ ]Department of Anesthesia and Critical Care, Pontchaillou University Hospital, University Rennes, Rennes, France
                [ ]Department of Intensive Care, Hospital of Roanne, Roanne, France
                [ ]Department of Anesthesia and Critical Care, University Charles Nicolle Hospital, University Rouen, Rouen, France
                [ ]Department of Anesthesia and Critical Care, University Hospital Civil of Strasbourg, University Strasbourg, Strasbourg, France
                [ ]Department of Anesthesia and Critical Care, Haut-Lévêque University Hospital, University Bordeaux, Bordeaux, France
                [ ]Medical-Surgical Intensive Care, District Hospital, La Roche Sur-Yon, France
                [ ]Department of Anesthesia and Critical Care, D′Estaing University Hospital, University Clermont-Ferrand, Clermont-Ferrand, France
                [ ]Department of Anesthesia and Surgical Intensive Care, La Milèterie University Hospital, Poitiers University, Poitiers, France
                [ ]Department of Medical Intensive Care, La Milèterie University Hospital, Poitiers University, Poitiers, France
                [ ]Department of Anesthesia and Critical Care, Trousseau University Hospital, University Tours, Tours, France
                [ ]Department of Anesthesia and Critical Care, Huriez University Hospital, University Lille, Lille, France
                [ ]Department of Anesthesia and Critical Care, University Hospital, Lille, France
                [ ]Department of Intensive Care, Saint-Jean Hospital, Perpignan, France
                [ ]Medical-Surgical Intensive Care, District Hospital, Saint-Malo, France
                [ ]Medical Intensive Care, La milèterie University Hospital, University Poitiers, Poitiers, France
                Article
                3751
                10.1007/s00134-015-3751-z
                4477725
                25862039
                © The Author(s) 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                Categories
                Seven-Day Profile Publication
                Custom metadata
                © Springer-Verlag Berlin Heidelberg and ESICM 2015

                Emergency medicine & Trauma

                septic shock, peritonitis, hemoperfusion, polymyxin b

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