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Score-based immunoglobulin G therapy of patients with sepsis: The SBITS study*

Author(s): Werdan K, Pilz G, Bujdoso O, Fraunberger P, Neeser G, Schmieder RE, Viell B, Marget W, Seewald M, Walger P, Stuttmann R, Speichermann N, Peckelsen C, Kurowski V, Osterhues HH, Verner L, Neumann R, Muller-Werdan U, for the Score-Based Immunoglobulin Therapy of Sepsis (SBITS) Study Group

Affiliation(s): From the Department of Medicine III, University Hospital, Martin-Luther-University Halle-Wittenberg, Germany (KW, UM-W); the Department of Medicine, Hospital Agatharied, Academic Teaching Hospital University of Munich, Germany (GP); Bayer HealthCare, Leverkusen, Germany and Berkeley, CA (OB, RN); the Medizinisches Zentrallaboratorium GesmbH, Feldkirch, Austria (PF); Central Hospital Augsburg, Department of Anaesthesiology and Intensive Care Medicine, Germany (GN); Department of Medicine, South-Hospital Nuremberg, University of Erlangen-Nurnberg, Germany (RSch); Medical Policlinics, University of Bonn, Germany (PW); Department of Anaesthesiology and Intensive Care Medicine, Klinikum Bergmannstrost, Halle/Saale, Germany (RSt); Department of Anaesthesiology, Hospital Ludwigsburg, Germany (NSp); Center of Acute Internal Medicine and Prevention, Stadtisches Klinikum Munchen GmbH-Klinikum Harlaching, Munich Municipal Clinic, Academic Teaching Clinic University of Munich, Germany (CP); Department of Medicine, University Hospital Lubeck, Germany (VK); Department of Medicine, University Hospital Ulm, Germany (H-HO); Department of Anaesthesiology, University Hospital Hannover, Germany (LV); Federal Institute for Risk Assessment (BfR), Berlin, Germany (BV); MedQM Berlin (MS); Department of Pediatrics, University of Munich, Germany (WM, emeritus). Additional institutions and investigators participating in the study are listed in the appendix.

Publication date & source: 2007-10-23, Crit Care Med., [Epub ahead of print]

OBJECTIVE:: Intravenous immunoglobulin as an adjunctive treatment in sepsis was regarded as promising by a Cochrane meta-analysis of smaller trials. In this phase III multicenter trial, we assessed whether intravenous immunoglobulin G (ivIgG) reduced 28-day mortality and improved morbidity in patients with score-defined severe sepsis. DESIGN:: Randomized, double-blind, placebo-controlled, multicenter trial. SETTING:: Twenty-three medical and surgical intensive care units in university centers and large teaching hospitals. PATIENTS:: Patients (n = 653) with score-defined sepsis (sepsis score 12-27) and score-defined sepsis-induced severity of disease (Acute Physiology and Chronic Health Evaluation II score 20-35). INTERVENTIONS:: Patients were assigned to receive either placebo or ivIgG (day 0, 0.6 g/kg body weight; day 1, 0.3 g/kg body weight). MEASUREMENTS AND MAIN RESULTS:: The prospectively defined primary end point was death from any cause after 28 days. Prospectively defined secondary end points were 7-day all-cause mortality, short-term-change in morbidity, and pulmonary function at day 4. Six hundred and fifty-three patients from 23 active centers formed the intention-to-treat group, 624 patients the per-protocol group (placebo group, n = 303; ivIgG group, n = 321). The 28-day mortality rate was 37.3% in the placebo group and 39.3% in the ivIgG group and thus not significantly different (p = .6695). Seven-day mortality was not reduced, and 4-day pulmonary function was not improved. Drug-related adverse events were rare in both groups. Exploratory findings revealed a 3-day shortening of mechanical ventilation in the surviving patients and no effect of ivIgG on plasma levels of interleukin-6 and tumor necrosis factor receptors I and II. CONCLUSIONS:: In patients with score-defined severe sepsis, ivIgG with a total dose of 0.9 g/kg body weight does not reduce mortality.

Page last updated: 2008-01-02

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