Mediastinitis is a rare but severe complication in patients after open heart surgery with cardiopulmonary bypass (CPB). The adjuvant application of IgM-enriched immunoglobulins (Pentaglobin®) was assumed to improve patients outcome and to reduce postoperative complications and infections.
In a prospective, placebo-controlled, double-blind randomized multicenter phase-III study, 125 patients were enrolled between 01/1999 and 04/2002 with postoperative mediastinitis after median sternotomy with CPB and reoperation for wound infection with at least 2 symptoms of systemic inflammation. Pentaglobin® or placebo was administered before wound revision and subsequently as a continuous infusion (5mg/kgBW/d for 5 days IV). Primary endpoint was the sum of daily therapeutic intervention scoring system points for 28 days (cumulative TISS-28). Secondary endpoints were ICU stay, change of MOF score and duration of wound infection.
One hundred and twenty-five patients were included, 64 received Pentaglobin®, and 61 placebo. Basic data were comparable. Efficacy analysis showed that the median cumulative TISS-28 was lower in the Pentaglobin group by 61 points (189 vs. 250 points, respectively) which on average corresponds to 2 days less of ICU. This difference was not significant (P=0.08; U-test, one-sided). Mean duration of intensive care (7.9±9.1 vs. 9.1±10.1 days), duration of wound infection (10.4±9.7 vs. 12.1±10.9 days) and the MOF score (14±35 vs. 17±37) were reduced as well in the Pentaglobin group. Adverse events were distributed equally. In each group 6 patients (10%) died.
The data demonstrate a clear tendency in favor IgM-enriched immunoglobulins as compared to placebo, although a statistical significance was missed.
G. Marggraf, None.