Tomoko Fujii1,2, Riki Ganeko3, Yuki Kataoka4, Toshi A Furukawa5, Robin Featherstone6, Kent Doi7, Jean-Louis Vincent8, Daniela Pasero9, René Robert10, Claudio Ronco11, Sean M Bagshaw12. 1. Department of Epidemiology and Preventive Medicine, Kyoto University Graduate School of Medicine, Yoshida Hon-machi, Sakyo-ku, Kyoto, Japan. 2. Japan Society for the Promotion of Science, 5-3-1 Kojimachi, Chiyoda-ku, Tokyo, Japan. 3. Department of Surgery, Kyoto University Hospital, 54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto, Japan. 4. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo, Japan. 5. Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-Ku, Kyoto, Japan. 6. Department of Pediatrics, Alberta Research Center for Health Evidence (ARCHE), University of Alberta, 11405-87 Avenue Edmonton, Alberta, Canada. 7. Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan. 8. Department of Intensive Care, Erasme University Hospital, Unversité Libre de Bruxelles, Route de Lennik 808, 1070, Brussels, Belgium. 9. Department of Anesthesia and Intensive Care Medicine, San Giovanni Battista Hospital, University of Turin, Via Giuseppe Verdi, 8, 10124, Turin, Italy. 10. Service de Réanimation Médicale, CHU-Poitiers, University of Poitiers, 86000, Poitiers, France. 11. Department of Nephrology Dialysis and Transplantation, International Renal Research Institute of Vicenza (IRRIV), San Bortolo Hospital, Viale Rodolfi 37, 36100, Vicenza, Italy. 12. Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124 Clinical Sciences Building, 8440-112 ST NW, Edmonton, Canada, T6G 2B7. bagshaw@ualberta.ca.
Abstract
PURPOSE: Polymyxin B-immobilized hemoperfusion (PMX-HP) is an adjuvant therapy for sepsis or septic shock that clears circulating endotoxin. Prior trials have shown that PMX-HP improves surrogate endpoints. We aimed to conduct an evidence synthesis to evaluate the efficacy and safety of PMX-HP in critically ill adult patients with sepsis or septic shock. METHODS: We searched for randomized controlled trials (RCTs) in MEDLINE, EMBASE, the Cochrane Library, the Health Technology Assessment Database, CINAHL, "Igaku Chuo Zasshi", the National Institute of Health Clinical Trials Register, the World Health Organization International Clinical Trials Registry Platform, the University Hospital Medical Information Network Clinical Trials Registry, the reference lists of retrieved articles, and publications by manufacturers of PMX-HP. The primary outcomes were 28-day all-cause mortality, the number of patients with at least one serious adverse event, and organ dysfunction scores. The GRADE methodology for the certainty of evidence was used. RESULTS: Six trials (857 participants; weighted mean age 62.5 years) proved eligible. Patient-oriented primary outcomes were assessed. The pooled risk ratio (RR) for 28-day mortality associated with PMX-HP was 1.03 [95% confidence interval (CI) 0.78-1.36; I 2 = 25%; n = 797]. The pooled RR for adverse events was 2.17 (95% CI 0.68-6.94; I 2 = 0%; n = 717). Organ dysfunction scores over 24-72 h after PMX-HP treatment did not change significantly (standardized mean difference - 0.26; 95% CI - 0.64 to 0.12; I 2 = 78%; n = 797). The certainty of the body of evidence was judged as low for both benefit and harm using the GRADE methodology. CONCLUSIONS: There is currently insufficient evidence to support the routine use of PMX-HP to treat patients with sepsis or septic shock. REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews (CRD42016038356).
PURPOSE: Polymyxin B-immobilized hemoperfusion (PMX-HP) is an adjuvant therapy for sepsis or septic shock that clears circulating endotoxin. Prior trials have shown that PMX-HP improves surrogate endpoints. We aimed to conduct an evidence synthesis to evaluate the efficacy and safety of PMX-HP in critically ill adult patients with sepsis or septic shock. METHODS: We searched for randomized controlled trials (RCTs) in MEDLINE, EMBASE, the Cochrane Library, the Health Technology Assessment Database, CINAHL, "Igaku Chuo Zasshi", the National Institute of Health Clinical Trials Register, the World Health Organization International Clinical Trials Registry Platform, the University Hospital Medical Information Network Clinical Trials Registry, the reference lists of retrieved articles, and publications by manufacturers of PMX-HP. The primary outcomes were 28-day all-cause mortality, the number of patients with at least one serious adverse event, and organ dysfunction scores. The GRADE methodology for the certainty of evidence was used. RESULTS: Six trials (857 participants; weighted mean age 62.5 years) proved eligible. Patient-oriented primary outcomes were assessed. The pooled risk ratio (RR) for 28-day mortality associated with PMX-HP was 1.03 [95% confidence interval (CI) 0.78-1.36; I 2 = 25%; n = 797]. The pooled RR for adverse events was 2.17 (95% CI 0.68-6.94; I 2 = 0%; n = 717). Organ dysfunction scores over 24-72 h after PMX-HP treatment did not change significantly (standardized mean difference - 0.26; 95% CI - 0.64 to 0.12; I 2 = 78%; n = 797). The certainty of the body of evidence was judged as low for both benefit and harm using the GRADE methodology. CONCLUSIONS: There is currently insufficient evidence to support the routine use of PMX-HP to treat patients with sepsis or septic shock. REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews (CRD42016038356).
Authors: Vincenzo Cantaluppi; Barbara Assenzio; Daniela Pasero; Giuseppe Mauriello Romanazzi; Alfonso Pacitti; Giacomo Lanfranco; Valeria Puntorieri; Erica L Martin; Luciana Mascia; Gianpaola Monti; Giampaolo Casella; Giuseppe Paolo Segoloni; Giovanni Camussi; V Marco Ranieri Journal: Intensive Care Med Date: 2008-05-08 Impact factor: 17.440