BACKGROUND: The recommendation to restrict the use of activated protein C (APC) to patients with severe sepsis and the highest risk of death originates from large trials that were subject to major exclusion criteria. OBJECTIVE: To investigate the effect of APC on prognosis in 'real world' patients. METHOD: Consecutive case series at tertiary care hospital including 63 adults with septic shock and multi-organ failure treated with APC (24 mcg/kg/h) for up to 96 h in addition to standard care. RESULTS: Median APACHE score was 35 (quartiles, 29-41), mean number of failing organs was 4 (quartiles, 4-5), and overall 30-day mortality was 48%. Independent predictors of 30-day mortality risk were the number of failing organs and number of antibiotics given. Risk of dying was significantly lower if compared with the mortality rates expected per APACHE II score category (P for trend per 5-point increment <0.001). This association was most prominent in patients with an APACHE II score of 30-44. Intracranial or major bleeding during APC treatment did not occur. CONCLUSION: These findings support the view that targeting APC treatment to patients with septic shock and a very high risk is a sound and safe approach. However, due to lack of consistent evidence from randomized studies APC was recently removed from the market.
BACKGROUND: The recommendation to restrict the use of activated protein C (APC) to patients with severe sepsis and the highest risk of death originates from large trials that were subject to major exclusion criteria. OBJECTIVE: To investigate the effect of APC on prognosis in 'real world' patients. METHOD: Consecutive case series at tertiary care hospital including 63 adults with septic shock and multi-organ failure treated with APC (24 mcg/kg/h) for up to 96 h in addition to standard care. RESULTS: Median APACHE score was 35 (quartiles, 29-41), mean number of failing organs was 4 (quartiles, 4-5), and overall 30-day mortality was 48%. Independent predictors of 30-day mortality risk were the number of failing organs and number of antibiotics given. Risk of dying was significantly lower if compared with the mortality rates expected per APACHE II score category (P for trend per 5-point increment <0.001). This association was most prominent in patients with an APACHE II score of 30-44. Intracranial or major bleeding during APC treatment did not occur. CONCLUSION: These findings support the view that targeting APC treatment to patients with septic shock and a very high risk is a sound and safe approach. However, due to lack of consistent evidence from randomized studies APC was recently removed from the market.
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