Articles: sepsis.
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Multicenter Study
Cost effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in the United Kingdom.
Drotrecogin alfa (activated) is licensed in Europe for the treatment of severe sepsis in patients with multiple organ failure. We constructed a model to assess the cost effectiveness of drotrecogin alfa (activated) from the perspective of the UK National Health Service when used in adult intensive care units. Patient outcomes from a 28-day international clinical trial (PROWESS) and a subsequent follow-up study (EVBI) were supplemented with UK data. ⋯ Applying the 28-day mortality outcomes of the PROWESS study, the model produced a cost per life year saved of 4608 UK pounds and cost per quality adjusted life year saved of 6679 UK pounds. Equivalent results using actual hospital outcomes were 7625 UK pounds per life year and 11,051 UK pounds per quality adjusted life year. Drotrecogin alfa (activated) appears cost effective in treating severe sepsis in UK intensive care units.
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To describe the incidence of three conditions of acute severe maternal morbidity in selected regions in nine European countries. ⋯ This study sets a simple and straightforward approach to the definition of three severe obstetric conditions and allows population-based comparisons between developed countries in Europe, even though difficulties may have been present with applying the definition across countries. The reported incidence of these severe obstetric conditions in general and severe haemorrhage varied significantly between countries. Overall, severe haemorrhage in particular was the most common of the three conditions, followed closely by severe pre-eclampsia.
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Intensive care medicine · Jan 2005
Multicenter StudyPost-ICU mortality in critically ill infected patients: an international study.
To determine the incidence and risk factors for post-ICU mortality in patients with infection. ⋯ Post-ICU death in patients with infection was within previously reported ranges in overall ICU populations. The main risk factors were patient and infection characteristics, severity at ICU admission, and persistent organ dysfunction at ICU discharge. Further interventions such as further ICU management, discharge to a step-down unit, or follow-up by intensivists on the ward should be evaluated in patients with a high risk of post-ICU mortality.
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Randomized Controlled Trial Multicenter Study Clinical Trial
[Activated protein C (the impact of PROWESS trial)].
The inflammatory response in severe sepsis is integrally linked to procoagulant activity and endothelial activation. The abnormalities in the microcirculation results in the development of septic organ dysfunction. The natural anticoagulant activated protein C is expected not only to improve the unbalanced coagulation/fibrinolysis system, but also to modulate the endothelial function, and to express the anti-inflammatory properties. ⋯ The results showed the statistically significant improved survival in patients with sepsis induced organ dysfunction (absolute risk reduction in 6.1%). As a result, activated protein C is recommended in patients at high risk of death such as Acute Physiology and Chronic Health Evaluation II > or = 25. However, since bleeding risk is reported as an adverse effect, activated protein C is contraindicated in patients with bleeding tendency.
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Critical care medicine · Dec 2004
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialSources of variability on the estimate of treatment effect in the PROWESS trial: implications for the design and conduct of future studies in severe sepsis.
To elucidate sources of variability in the estimate of treatment effects in a successful phase 3 trial in severe sepsis and to assess their implications on the design of future clinical trials. ⋯ A learning curve appeared to be present within the PROWESS trial such that the ability to demonstrate efficacy improved with increasing site experience. This potential learning curve may have implications for design of future trials. Investigational sites may need to require a minimum level of protocol-specific experience to appropriately implement a given trial. This experience should be an important consideration in designing trials and analysis plans. Diligence by coordinating centers, site investigators, study coordinators, and sponsors is necessary to ensure that the protocol is executed as designed such that a treatment benefit, if present, will be evident.