Abstract | INTRODUCTION: METHODS: A retrospective analysis of placebo-controlled, open-label, and compassionate-use trials was conducted. Adult patients received infusions of either DrotAA or placebo. All pediatric patients (<18 years old) received DrotAA. 189 adult and 121 pediatric patients presented with PF/MEN/MD. RESULTS: Fewer adult patients with PF/MEN/MD met cardiovascular (68.3% versus 78.8%) or respiratory (57.8% versus 80.5%) organ dysfunction entry criteria than those without. DrotAA-treated adult patients with PF/MEN/MD (n = 163) had an observed 28-day mortality rate of 19.0%, a 28-day serious bleeding event (SBE) rate of 6.1%, and an intracranial hemorrhage (ICH) rate of 4.3%. Six of the seven ICHs occurred in patients with MEN (three of whom were more than 65 years old with a history of hypertension). DrotAA-treated adult patients without PF/MEN/MD (n = 3,088) had an observed 28-day mortality rate of 25.5%, a 28-day SBE rate of 5.8%, and an ICH rate of 1.0%. In contrast, a greater number of pediatric patients with PF/MEN/MD met the cardiovascular organ dysfunction entry criterion (93.5% versus 82.5%) than those without. DrotAA-treated PF/MEN/MD pediatric patients (n = 119) had a 14-day mortality rate of 10.1%, an SBE rate of 5.9%, and an ICH rate of 2.5%. DrotAA-treated pediatric patients without PF/MEN/MD (n = 142) had a 14-day mortality rate of 14.1%, an SBE rate of 9.2%, and an ICH rate of 3.5%. CONCLUSION: DrotAA-treated adult patients with severe sepsis presenting with PF/MEN/MD had a similar SBE rate, a lower observed 28-day mortality rate, and a higher observed rate of ICH than DrotAA-treated patients without PF/MEN/MD. DrotAA-treated pediatric patients with severe sepsis with PF/MEN/MD may differ from adults, because all three outcome rates (SBE, mortality, and ICH) were lower in pediatric patients with PF/MEN/MD.
|
Authors | Jean-Louis Vincent, Simon Nadel, Demetrios J Kutsogiannis, R T Noel Gibney, S Betty Yan, Virginia L Wyss, Joan E Bailey, Carol L Mitchell, Samiha Sarwat, Stephen M Shinall, Jonathan M Janes |
Journal | Critical care (London, England)
(Crit Care)
Vol. 9
Issue 4
Pg. R331-43
(Aug 2005)
ISSN: 1466-609X [Electronic] England |
PMID | 16137345
(Publication Type: Comparative Study, Journal Article)
|
Chemical References |
- Anti-Infective Agents
- Protein C
- Recombinant Proteins
- drotrecogin alfa activated
|
Topics |
- Adult
- Aged
- Anti-Infective Agents
(therapeutic use)
- Child
- Child, Preschool
- Comorbidity
- Female
- Hemorrhage
(epidemiology)
- Humans
- IgA Vasculitis
(epidemiology)
- Intracranial Hemorrhages
(epidemiology)
- Male
- Meningitis, Bacterial
(epidemiology)
- Meningococcal Infections
(epidemiology)
- Middle Aged
- Odds Ratio
- Protein C
(therapeutic use)
- Recombinant Proteins
(therapeutic use)
- Retrospective Studies
- Sepsis
(drug therapy, epidemiology)
- Survival Analysis
- Treatment Outcome
|