Administration of a standardized plasma-protein solution (Biseko^®) in high-risk patients with systemic inflammatory response syndrome: influence on cytokine levels and survival

Introduction

Morbidity and mortality in patients suffering from systemic inflammatory response syndrome (SIRS) remain high. The present study was carried out because proteins might serve as promising agents to reduce mortality in SIRS patients. We therefore investigated the effects of a plasma-protein solution containing immunoglobulins on serum cytokine levels and survival.

Methods

This prospective, double-blind, randomized, controlled trial was performed in the medical ICU of a university hospital. Forty consecutive patients with SIRS were randomized to receive either a commercially available standardized plasma-protein solution (Biseko^®; Biotest, Dreieich, Germany) [1] consisting of all important transport and inhibitor proteins as well as immunoglobulins or a 5% albumin solution. Plasma/albumin was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following 4 days. Serum cytokine levels of IL-1β and IL-6 were measured on days 1–6, TNFα and TNF-R levels were determined on days 1 and 14 and at day 28. Survival was assessed on day 28 and on day 180.

Results

Eighteen patients received Biseko^®, 20 patients received albumin. Two patients died before receiving the complete study medication. During days 1–6 of the study period, serum levels of IL-1β were significantly lower in patients with Biseko^® therapy compared with patients receiving albumin (IL-1β AUC 65 ± 71 days.pg/ml vs 111 ± 157 days.pg/ml, P = 0.03). No statistically significant difference could be found in serum levels of IL-6, TNFα and TNF-R between both groups. While a not statistically significant trend towards better survival could be observed in the Biseko^® group on day 28, the survival rate on day 180 was significantly higher in the Biseko^® group (50% (9/18)) vs the albumin group (10% (2/20), (P < 0.008)).

Conclusion

The data suggest that Biseko^® therapy was associated with significantly lower IL-1β plasma concentrations (days 1–6) and with improved survival rates.