Prowess-shock trial: a protocol overview and perspectives

Sepsis remains a challenge for intensive care physicians, as it keeps up with high mortality rate in spite of the high costs associated with its treatment. Several studies indicate that the infusion of Drotrecogin-alpha activated (DrotAA) reduce mortality in patients at high risk of death when admin...

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Bibliographic Details
Published in:Shock (Augusta, Ga.) Ga.), 2010-09, Vol.34 Suppl 1 (7), p.48-53
Main Authors: Silva, Eliézer, de Figueiredo, Luiz Francisco Poli, Colombari, Fernando
Format: Article
Language:English
Subjects:
Adult
Animals
APACHE
Blood Coagulation Factors - metabolism
Clinical Protocols
Double-Blind Method
Europe
Fibrinolysis
Health Promotion
Humans
Inflammation
International Cooperation
Multicenter Studies as Topic - methods
Multicenter Studies as Topic - statistics & numerical data
Multiple Organ Failure - drug therapy
Multiple Organ Failure - etiology
Multiple Organ Failure - mortality
Protein C - adverse effects
Protein C - therapeutic use
Randomized Controlled Trials as Topic - methods
Randomized Controlled Trials as Topic - statistics & numerical data
Recombinant Proteins - adverse effects
Recombinant Proteins - therapeutic use
Research Design
Shock, Septic - drug therapy
Shock, Septic - mortality
Thrombophilia - drug therapy
Thrombophilia - etiology
Thrombophilia - physiopathology
United States
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Summary:Sepsis remains a challenge for intensive care physicians, as it keeps up with high mortality rate in spite of the high costs associated with its treatment. Several studies indicate that the infusion of Drotrecogin-alpha activated (DrotAA) reduce mortality in patients at high risk of death when administered early and secured the appropriate initial treatment of sepsis as recommended by Surviving Sepsis Campaign. Europe and United States of America differ regarding the criteria of high risk of death in sepsis, two or more organ dysfunctions and Acute Physiology and Chronic Health Evaluation 25 or more, respectively. In addition to varied definitions of high risk of death for inclusion of patients in sepsis studies, the possibility of bleeding related to drug use and intrinsic limitations related to study design led the Company to develop a new randomized, multinational, placebo-controlled, double-blind study to assess the effectiveness of drug in patients with septic shock in adults.
ISSN:1073-2322
1540-0514
DOI:10.1097/SHK.0b013e3181e7e97b