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 (50. IU/kg bolus followed by continuous infusion of 3. IU/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.