Administration of Protein C Concentrates in Adult Critically Ill Septic Patients
Status:
Terminated
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Severe sepsis and septic shock are life threatening medical emergencies and are among the
most significant challenges in critical care. Case reports and case series suggest that
plasma-derived protein C concentrate may improve the outcome of patients with acquired
protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in
modulating overwhelming inflammation and preventing coagulation derangements, two key
mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience
collected through these studies shows that PC is safe, in that it is not associated with
bleeding or severe allergic complications,and possibly useful, at least to improve the
coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes
from case series or case reports or an underpowered randomized controlled study. A randomized
clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary
to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has
clinically relevant implications in terms of reduction of thromboembolic events, 30 days
mortality, length of intensive care and hospital stay, time on mechanical ventilation, length
of ICU and hospital stay. The study will also confirm that there is no bleeding concern with
the use of Protein C concentrates.The study drug will be administered in the Intensive Care
Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be
performed at 30 days and at one year.