International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: 28-day survival and safety.
J Crit Care
; 22(2): 142-52, 2007 Jun.
Article
en En
| MEDLINE
| ID: mdl-17548026
ABSTRACT
PURPOSE:
To enhance the understanding of severe sepsis, a database of patients from multiple clinical trials spanning a 6-year period was constructed. Initial analyses evaluated the 28-day survival in the placebo group and further assessed the treatment effect of drotrecogin alfa (activated) (DrotAA).METHODS:
Five severe sepsis studies with similar entry criteria were combined, and baseline characteristics and 28-day mortality were evaluated (4459 severe sepsis patients; placebo, n = 1231; DrotAA, n = 3228). An integrated data analysis with propensity score adjustment was performed. Twenty-one variables selected by stepwise logistic regression were included in a propensity score of differences between the 2 groups of patients.RESULTS:
Over the 6-year period of these trials, there was no change in placebo mortality rates overall (P = .67), nor in subgroups of Acute Physiology and Chronic Health Evaluation score >/=25 (P = .73) or multiple organ dysfunction (P = .38). The adjusted relative hazard risk for DrotAA patients was 0.84 (95% confidence interval, 0.73-0.95; P = .007). Serious bleeding (0.8% in placebo vs 3.5% in DrotAA, P < .0001) was increased during the DrotAA infusion period.CONCLUSIONS:
Initial analyses indicate that placebo mortality remained unchanged over a recent 6-year period. These analyses also further substantiate that treatment with DrotAA is associated with improved survival.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proteína C
/
Bases de Datos Factuales
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Sepsis
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
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Antiinfecciosos
Tipo de estudio:
Clinical_trials
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Prognostic_studies
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Risk_factors_studies
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Systematic_reviews
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Crit Care
Asunto de la revista:
TERAPIA INTENSIVA
Año:
2007
Tipo del documento:
Article
País de afiliación:
Bélgica