Cooperative Group of Additional Immunoglobulin Therapy in Severe Bacterial Infections: results of a multicenter randomized controlled trial in cases of diffuse fibrinopurulent peritonitis

Abstract

A multicenter randomized controlled clinical trial, which was carried out in 10 hospitals in the Federal Republic of Germany between 1979 and 1983, studied the influence of i.v. immunoglobulin G on the mortality in patients with diffuse acute fibrinopurulent peritonitis. Altogether 288 patients were enrolled in the trial. There was no statistically significant difference in the mortality rates within the treated group (46%) vs the control group (41%). The power of the statistical test to detect a decrease of the mortality by 20% was calculated to be 0.93. This result did not change when we eliminated 50 patients not strictly obeying the entrance criteria of the analysis, or when we focused on a subgroup of patients with initial deficiency of immunoglobulin G. Factors influencing mortality were a preceding laparotomy, serum creatinine level above 2 mg/100 ml, and necessity for artificial respiration. These factors, reflecting the surgical situation and the severity of shock, essentially explain the mortality differences observed between the participating hospitals.