Articles: sepsis.
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Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial
Extended evaluation of recombinant human activated protein C United States Trial (ENHANCE US): a single-arm, phase 3B, multicenter study of drotrecogin alfa (activated) in severe sepsis.
To gather additional 28-day all-cause mortality and safety data among adult patients with severe sepsis who were treated with drotrecogin alfa (activated). ⋯ Despite the limitations associated with comparisons across trials, this study provides confirmatory evidence of the efficacy and safety of drotrecogin alfa (activated) documented in the PROWESS trial.
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Critical care medicine · May 2004
Randomized Controlled Trial Multicenter Study Clinical TrialCD14 receptor occupancy in severe sepsis: results of a phase I clinical trial with a recombinant chimeric CD14 monoclonal antibody (IC14).
Binding of bacterial cell wall components to CD14 and co-receptors on myeloid cells results in cellular activation and production of proinflammatory mediators. A recombinant anti-CD14 monoclonal antibody (IC14) has been shown to decrease lipopolysaccharide-induced responses in animal and human models of endotoxemia. This study was performed to evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical pharmacology of IC14 in patients with severe sepsis. ⋯ Single and multiple doses of IC14 were generally well tolerated and did not induce antibody formation or increase the incidence of secondary bacterial infection. The results suggest that CD14 blockade with IC14 warrants further clinical investigation to determine its ability to attenuate the proinflammatory response due to infection.
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Intensive care medicine · Apr 2004
Multicenter StudyEPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units.
Ten years ago 8.4% of patients in French intensive care units (ICUs) were found to have severe sepsis or shock and 56% died in the hospital. As novel therapies for severe sepsis are emerging, updated epidemiological information is required. ⋯ Although the attack rate of severe sepsis in French ICUs appears to have increased over the past decade, its associated mortality has decreased, suggesting improved management of patients. Severe sepsis incurs considerable resources use, and implementation of effective management strategies and continued research efforts are needed.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Universal changes in biomarkers of coagulation and inflammation occur in patients with severe sepsis, regardless of causative micro-organism [ISRCTN74215569].
PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) was a phase III, randomized, double blind, placebo controlled, multicenter trial conducted in patients with severe sepsis from 164 medical centers. Here we report data collected at study entry for 1690 patients and over the following 7 days for the 840 patients who received placebo (in addition to usual standard of care). ⋯ Abnormalities in biomarkers of inflammation and coagulation were related to disease severity and mortality outcome in patients with severe sepsis. Coagulopathy and inflammation were universal host responses to infection in patients with severe sepsis, which were similar across causative micro-organism groups.
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Tidsskr. Nor. Laegeforen. · Mar 2004
Multicenter Study Clinical Trial[Severe sepsis treated with activated protein C].
Severe sepsis is a common cause of mortality in critically ill patients. Drotrecogin alfa (activated), synonymous with recombinant human activated protein C (rhAPC), is a new therapeutic tool with anticoagulant, anti-inflammatory and profibrinolytic properties with proven effect in reducing mortality in severe sepsis. ⋯ Treatment with rhAPC is easily carried out in an intensive care unit. Patients with severe sepsis and two or more failing vital organs should be considered for treatment with rhAPC.