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Human recombinant activated protein C for severe sepsis
Arturo J Martí-Carvajal1, Ivan Solà, Dimitrios Lathyris
1Universidad de Carabobo and Iberoamerican Cochrane Network, Valencia, Edo. Carabobo, Venezuela.
The Cochrane Database of Systematic Reviews
|April 15, 2011
Summary
Human recombinant activated protein C (APC) does not reduce mortality in severe sepsis or septic shock and increases bleeding risk. Further research is needed before promoting APC use in clinical practice.
Area of Science:
- Critical Care Medicine
- Pharmacology
- Clinical Trials
Background:
- Sepsis is a life-threatening condition with high mortality rates.
- Human recombinant activated protein C (APC) has been investigated as a treatment to reduce sepsis-related deaths.
- This review is an update of previous Cochrane reviews on APC for severe sepsis.
Purpose of the Study:
- To assess the clinical effectiveness and safety of APC for treating severe sepsis or septic shock.
- To evaluate the impact of APC on all-cause mortality and hospital mortality.
- To identify any increased risks associated with APC treatment.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials (RCTs).
- Searched multiple databases (CENTRAL, MEDLINE, EMBASE, BIOSIS, CINAHL, LILACS) without language restrictions.
- Included RCTs in adults and children (excluding neonates), focusing on mortality and bleeding events.
Main Results:
- Five RCTs with 5101 participants were included.
- APC did not significantly reduce 28-day mortality in adult severe sepsis patients (RR 0.97, 95% CI 0.78 to 1.22).
- APC use was associated with a significantly increased risk of bleeding (RR 1.47, 95% CI 1.09 to 2.00) and did not reduce mortality in pediatric patients.
Conclusions:
- Current evidence does not support the use of APC for treating severe sepsis or septic shock.
- APC treatment is linked to an elevated risk of bleeding.
- Promotion of APC use should be avoided unless future RCTs demonstrate a clear treatment benefit.
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