OBJECTIVE To evaluate the effect of intravenous IgMA-enriched immunoglobulin (ivIGMA) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock. DESIGN Multiple-center, prospective randomized, controlled study. SETTING Six university hospitals in Germany. PATIENTS Patients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999. INTERVENTIONS
Patients 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 RESULTS All-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. CONCLUSIONS Intravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock.
