Cooperative group of additional immunoglobulin therapy in severe bacterial infections: Results of a multicenter randomized controlled trial in cases of diffuse fibrinopurulent peritonitis

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