• Karl Werdan, Günter Pilz, Oskar Bujdoso, Peter Fraunberger, Gertraud Neeser, Roland Erich Schmieder, Burkhard Viell, Walter Marget, Margret Seewald, Peter Walger, Ralph Stuttmann, Norbert Speichermann, Claus Peckelsen, Volkhard Kurowski, Hans-Heinrich Osterhues, Ljiljana Verner, Roswita Neumann, Ursula Müller-Werdan, and Score-Based Immunoglobulin Therapy of Sepsis (SBITS) Study Group.
• Department of Medicine III, University Hospital, Martin-Luther-University Halle-Wittenberg, Germany. karl.werdan@medizin.uni-halle.de
• Crit. Care Med. 2007 Dec 1;35(12):2693-2701.

ObjectiveIntravenous 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.DesignRandomized, double-blind, placebo-controlled, multicenter trial.SettingTwenty-three medical and surgical intensive care units in university centers and large teaching hospitals.PatientsPatients (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).InterventionsPatients 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 ResultsThe 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 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.ConclusionsIn patients with score-defined severe sepsis, ivIgG with a total dose of 0.9 g/kg body weight does not reduce mortality.

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