tailieunhanh - Báo cáo y học: " Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated)"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về ngành y học đề tài: Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated). | Shorr et al. Critical Care 2010 14 R229 http content 14 6 R229 KS CRITICAL CARE RESEARCH Open Access Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa activated Andrew F Shorr1 Jonathan M Janes2 Antonio Artigas3 Jyrki Tenhunen4 Duncan LA Wyncoll5 Emmanuelle Mercier6 Bruno Francois7 Jean-Louis Vincent8 Burkhard Vangerow2 Darell Heiselman2 Amy G Leishman2 Yajun E Zhu2 Konrad Reinhart9 for the RESPOND investigators Abstract Introduction Serial alterations in protein C levels appear to correlate with disease severity in patients with severe sepsis and it may be possible to tailor severe sepsis therapy with the use of this biomarker. The purpose of this study was to evaluate the dose and duration of drotrecogin alfa activated treatment using serial measurements of protein C compared to standard therapy in patients with severe sepsis. Methods This was a phase 2 multicenter randomized double-blind controlled study. Adult patients with two or more sepsis-induced organ dysfunctions were enrolled. Protein C deficient patients were randomized to standard therapy 24 gg kg hr infusion for 96 hours or alternative therapy higher dose and or variable duration 24 30 36 gg kg hr for 48 to 168 hours . The primary outcome was a change in protein C level in the alternative therapy group between study Day 1 and Day 7 compared to standard therapy. Results Of 557 patients enrolled 433 patients received randomized therapy 206 alternative and 227 standard. Baseline characteristics of the groups were largely similar. The difference in absolute change in protein C from Day 1 to Day 7 between the two therapy groups was 7 P . Higher doses and longer infusions were associated with a more pronounced increase in protein C level with no serious bleeding events. The same doses and longer infusions were associated with a larger increase in protein C level higher rates of serious bleeding when groups received