Articles: sepsis.
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Critical care medicine · Feb 2004
Randomized Controlled Trial Multicenter Study Clinical TrialRecombinant human platelet-activating factor acetylhydrolase for treatment of severe sepsis: results of a phase III, multicenter, randomized, double-blind, placebo-controlled, clinical trial.
Platelet-activating factor (PAF) and structurally-related oxidized phospholipids are proinflammatory mediators in systemic inflammatory states such as severe sepsis. The enzyme platelet-activating factor acetylhydrolase (PAF-AH) rapidly degrades PAF and oxidized phospholipids into inactive metabolites. Reduced PAF-AH activity has been observed in patients with severe sepsis and may contribute to their systemic inflammatory response and organ dysfunction. A previous clinical trial with recombinant human PAF-AH (rPAF-AH, Pafase) suggested that this treatment may decrease 28-day all-cause mortality in patients with severe sepsis. The current study was undertaken to confirm this result. ⋯ rPAF-AH was well tolerated and not antigenic, but did not decrease 28-day all-cause mortality in patients with severe sepsis.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Adequacy of early empiric antibiotic treatment and survival in severe sepsis: experience from the MONARCS trial.
As part of the Monoclonal Anti-TNF: A Randomized Controlled Sepsis (MONARCS) trial, which enrolled patients with suspected sepsis, we sought to determine whether adequate antibiotic therapy was associated with a decreased mortality rate. The study enrolled 2634 patients, 91% of whom received adequate antibiotic therapy. The mortality rate among patients given adequate antibiotic treatment was 33%, versus 43% among patients given inadequate treatment (P<.001). We conclude that adequate antibiotic therapy results in a significant decrease in the crude mortality rate among patients suspected of sepsis.
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Randomized Controlled Trial Multicenter Study Clinical Trial
[Cost-effectiveness of drotrecogin alpha [activated] in the treatment of severe sepsis in Spain].
The PROWESS clinical trial has shown that treatment with drotrecogin alpha (activated) in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment. The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha (activated) versus that of standard care in the treatment of severe sepsis in Spain. ⋯ Treatment with drotrecogin alfa (activated) presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain.
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Multicenter Study Clinical Trial Controlled Clinical Trial
Safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in children with severe sepsis.
In a phase 3 trial, recombinant human activated protein C (drotrecogin alfa [activated]) significantly reduced mortality in adult patients with severe sepsis. We have now performed a preliminary analysis of the safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in pediatric patients with severe sepsis. ⋯ Pediatric patients with severe sepsis manifest sepsis-induced coagulopathy including protein C deficiency comparable to that seen in adults with severe sepsis. The pharmacokinetics, pharmacodynamic effects, and safety profile of drotrecogin alfa (activated) in pediatric patients are similar to those previously published for adult patients. A large, phase 3, randomized, placebo-controlled study is ongoing to confirm these results and formally assess the safety and efficacy of drotrecogin alfa (activated) in children.
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B Acad Nat Med Paris · Jan 2004
Multicenter Study Comparative Study[Epidemiology of infection and sepsis in intensive care unit patients].
Since 1992, epidemiological and clinical studies have classified severe infections into three categories: sepsis, severe sepsis and septic shock. Microbiological documentation is not always provided. We used a different approach, focusing on the infection itself, whether or not it is microbiologically documented or associated with sepsis. ⋯ The in-hospital mortality rate increased with severity, from 20% for sepsis to 40% for severe sepsis and 60% for septic shock, but also depended on the origin of infection (community vs hospital/ICU). Crude incidence rates of ICU infection were high, varying among ICUs and patient subsets. Thus, vital outcome depends not only on the severity of sepsis but also on the characteristics of the infection.