• Marcus Hentrich, Karl Fehnle, Helmut Ostermann, Joachim Kienast, Oliver Cornely, Christoph Salat, Ralf Ubelacker, Dieter Buchheidt, Gerhard Behre, Wolfgang Hiddemann, and Xaver Schiel.
• Department of Internal Medicine III, University Hospital Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany.
• Crit. Care Med. 2006 May 1;34(5):1319-25.

ObjectiveTo evaluate the effect of intravenous IgMA-enriched immunoglobulin (ivIGMA) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock.DesignMultiple-center, prospective randomized, controlled study.SettingSix university hospitals in Germany.PatientsPatients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999.InterventionsPatients received 1300 mL of ivIGMA (7.8 g IgM, 7.8 g IgA, and 49.4 g IgG) infused intravenously within a period of 72 hrs or human albumin according to the same schedule as ivIGMA.Measurements And Main ResultsAll-cause mortality at 28 days, sepsis-related mortality at 28 days, all-cause mortality at 60 days, mortality from septic shock, and mortality from microbiologically proven Gram-negative sepsis and septic shock were recorded. Immunoglobulin had no benefit over human albumin. The 28-day mortality rate was 26.2% and 28.2% in the ivIGMA and control patients, respectively (difference, 2.0% [95% confidence interval, -10.2 to 14.2 percentage points]). Likewise, the 60-day mortality rate did not differ between both arms (29.6% vs. 34.7% in the ivIGMA and control patients, respectively). Mortality rates in patients with sepsis syndrome (17.1% vs. 16.7%) and septic shock (51.9% vs. 54.8%) were also found to be similar between both groups.ConclusionsIntravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock.

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