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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. arturo.marti.carvajal@gmail.com.
The Cochrane Database of Systematic Reviews
|March 16, 2012
Summary
Human recombinant activated protein C (APC) did not reduce mortality in severe sepsis patients and increased bleeding risk. Current evidence does not support APC use for sepsis treatment.
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) was 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 APC's impact 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), analyzing mortality and bleeding events.
Main Results:
- Five RCTs with 5101 participants were included.
- APC did not significantly reduce 28-day mortality in adult sepsis patients (RR 0.97, 95% CI 0.78-1.22).
- APC use was associated with a significantly increased risk of bleeding (RR 1.47, 95% CI 1.09-2.00).
Conclusions:
- No evidence supports the use of APC for treating severe sepsis or septic shock.
- APC is linked to an increased risk of bleeding complications.
- Policy-makers and clinicians should not promote APC use unless further RCTs demonstrate a clear treatment benefit.
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