Treatment of Gram-negative septic shock with an immunoglobulin preparation: A prospective, randomized clinical trial

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Objective:To evaluate the effectiveness of a polyclonal immunoglobulin (Ig) preparation containing IgG, IgM, and IgA as an adjunctive therapy for septic shock.Design:Prospective, randomized clinical trial.Setting:A clinical immunology ward at the center for internal medicine in a university hospital.Patients:Fifty-five patients with septic shock were randomly allocated to two groups according to criteria of septic shock.Intervention:One group of patients (n = 27) received a commercially available immunoglobulin preparation (containing high titers of antibodies specific for determinants to bacterial endotoxin) during the first 3 days after inclusion in the study. The other randomized group (n = 28) did not receive any immunoglobulin preparation.Measurements and Main Results:During the period of ≤6 wks after the beginning of clinically apparent septic shock, death related to the septic process occurred in one (4%) of 27 patients who received immunoglobulin. By comparison, nine (32%) of 28 control group patients died during this period (p <.01 ). Within the first 48 hrs after onset of the clinically apparent septic process, significantly increased activity of circulating endotoxin and simultaneously decreased specific IgG serum titers to lipid A were detected in the group of nonsurvivors.Conclusions:Administration of a polyclonal immunoglobulin preparation in the early phase of septic shock was associated with significantly improved survival.

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