randomized trial evaluating serial protein c levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated)随机试验评估连环蛋白c水平严重脓毒症患者可变剂量的drotrecogin阿尔法(激活).pdfVIP
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randomized trial evaluating serial protein c levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated)随机试验评估连环蛋白c水平严重脓毒症患者可变剂量的drotrecogin阿尔法(激活)
Shorr et al. Critical Care 2010, 14:R229
/content/14/6/R229
RESEARCH Open Access
Randomized trial evaluating serial protein C levels
in severe sepsis patients treated with variable
doses of drotrecogin alfa (activated)
1* 2 3 4 5
Andrew F Shorr , Jonathan M Janes , Antonio Artigas , Jyrki Tenhunen , Duncan LA Wyncoll ,
6 7 8 2 2
Emmanuelle Mercier , Bruno Francois , Jean-Louis Vincent , Burkhard Vangerow , Darell Heiselman ,
2 2 9
Amy G Leishman , Yajun E Zhu , Konrad Reinhart , 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 μg/kg/hr infusion for 96 hours) or alternative therapy (higher dose and/or variable duration; 24/30/
36 μg/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
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