SUPPLEMENTAL TREATMENT OF SEPSIS WITH INTRAVENOUS POLYVALENT IMMUNOGLOBULIN-G AND PSEUDOMONAS IMMUNOGLOBULIN - RESULTS OF AN OBSERVATIONAL STUDY IN 163 PATIENTS

The impact of i.v. immunoglobulin (IVIG) therapy on the survival of adult septic patients cannot yet be considered either proved or disproved. To define optimal criteria for a large multicenter placebo-controlled trial, a multicenter observational study was carried out in 163 medical and surgical patients exhibiting a total of 173 episodes of sepsis and septic shock [Elebute (El) sepsis score; 19 +/- 0.5). The effects of supplemental IVIG treatment (unmodified polyvalent IgG, pH 4.25, n = 123; for Pseudomonas sepsis, n = 50, Pseudomonas IgG) on multiple-organ failure (MOF) were investigated according to changes in the APACHE II score (AP) (pretreatment value 23.7 +/- 0.6). In 44% of the cases ("responders"), a prompt improvement in AP (defined as a decrease of greater-than-or-equal-to 4) was evident from day 0 to day 4 after the onset of therapy, thus showing a close temporal relationship to IVIG administration. This improvement, associated with an improved prognosis (mortality, 24% vs 55%), was found in all subgroups, most importantly, polyvalent IgG vs Pseudomonas IgG treatment; medical vs surgical patients; moderate vs severe MOF; and gram-positive vs gram-negative septicemia. Thus, all of these patients should be included in future placebo-controlled, randomized IVIG trials. The ranges of optimal baseline scores for patient inclusion were found to be 20-35 for AP and 12-27 for El. The possible effectiveness of IVIG was further suggested by the results obtained in a small, second, comparative, non-randomized control group (n = 27, antibiotic treatment alone) of septic subjects (El; 14.7 +/- 1) displaying similar MOF severity (AP, 23.6 +/- 1.4), whose response rate (30%) was lower by one-third, although this difference was not statistically significant.