Septic Shock Clinical Trial
Official title:
Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock
Septic shock still places a burden in the healthcare system round around the world. In the
early 20ties, clinical trials suggested potential benefits from activated protein C in
severe sepsis and of corticosteroids when given to adults with refractory shock. More recent
studies suggested that patients with moderate sepsis or septic shock may not benefit from
either activated protein C or corticosteroids. Therefore, current international guidelines
suggest that physicians may consider using these drugs in the more severe cases of sepsis.
The main risk associated with the use of activated protein C is bleeding and the main risk
associated with the use of steroids is superinfection. It is paramount that a new adequately
powered trial explores the benefit/risk ratio of these two drugs and of their combination in
a population of adult patients with septic shock.
After the withdrawal of Xigris in October 2011, the study was suspended and restarted in
June 2012 to investigate the benefit to risk ratio of corticosteroids.
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