Protein C zymogen in adults with severe sepsis or septic shock

Introduction: Activated protein C is associated with a risk of bleeding and its effects on survival in septic shock patients are questionable. Protein C zymogen has no risk of bleeding and improves the outcome of patients with septic shock. We hereby describe the largest published case series of adult patients receiving protein C zymogen. Design, setting and participants: A prospective study on 23 adult patients with severe sepsis or septic shock, two or more organ failures and at high risk for bleeding, treated with protein C zymogen (501U/kg bolus followed by continuous infusion of 31U/kg/h for 72 h). Results: The Z-test evidenced a significant reduction between the expected mortality (53%) and the observed mortality 30% (Z value =1.99, p=0.046) in our sample population. Protein C levels increased from 34 +/- 18% to 66 +/- 22% at 6 h after PC bolus (p<0.001), and kept on increasing during 72 h of administration (p<0.001 to baseline). Sequential Organ Failure Assessment (SOFA), score of organ dysfunction, decreased from baseline to 7 days after administration of protein C from 14 +/- 2 to 7 +/- 4 (p<0.001). No adverse event drug related was noted. Conclusion: Protein C zymogen administration is safe and its use in septic patients should be investigated through a randomized controlled trial. (C) 2012 Elsevier Espana, S.L. and SEMICYUC. All rights reserved.