IgM-enriched immunoglobulin preparation for immunoprophylaxis in cardiac surgery.

OBJECTIVE: Evaluating the effects of prophylactic administration of IgM-enriched immunoglobulins (IVIG) on immunological- and clinical parameters in cardiac surgical patients. PATIENTS AND METHODS: 41 patients were randomized to receive either an IgM-enriched immunoglobulin (Pentaglobin(R)) preparation (1,300 ml immunoglobulin, equivalent to 65 g protein) combined with routine antibiotic prophylaxis (Group A; n = 20, 1 drop-out), or routine antibiotic prophylaxis plus placebo (Group B; n = 20). Patients were comparable with respect to their APACHE II score, comorbidity, coronary risk, operating time, clamp, and ischemic time. Endotoxin and endotoxin neutralizing capacity (ENC) were determined by a kinetic turbidimetric Limulus amebocyte lysate (LAL) assay with internal standardization. Serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF)-alpha, soluble TNF-Receptor I (sTNF-R1), and interleukin-10 (IL-10) were determined by ELISA. Data analysis was performed by area under the curve (AUC) calculation and ANOVA for endotoxin neutralizing capacity and by ANOVA for all other cases. RESULTS: All patients survived. Endotoxin plasma levels were generally but not significantly higher in group A than in controls, while the difference in endotoxin neutralizing capacity (ENC) reached significance. IL-6, TNF-alpha, IL-10 and TNF-R1 were not different between both groups, however. There were significantly less patients with signs of inflammation (fever, leukocytosis, hypotension) in group A (group A n = 2; group B n = 9; p<0.05). This was paralleled by a slightly reduced hospitalization period in group A patients compared to group B patients (A:12.05 +/- 3.66 vs. B:13.45 +/- 3.72 days; n.s.). All data are given as mean +/- standard deviation (SD). CONCLUSION: The results of this study support that IgM-enriched IVIG preparation are effective when used prophylactically in patients undergoing procedures with cardiopulmonary bypass. The mechanisms of endotoxin neutralization and the effect of the host immune status on the efficacy of IVIG treatment remain to be elucidated.