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 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.
Intensive Care Unit, Hospital Israelita Albert Einstein, Universidade de São Paulo, São Paulo, Brazil. eliezer@einstein.br
Eliézer
E
Silva
Luiz Francisco Poli
LF
de Figueiredo
Fernando
F
Colombari
D018806:APACHE; D000328:Adult; D000818:Animals; D001779:Blood Coagulation Factors / Q000378:metabolism; D002985:Clinical Protocols; D004311:Double-Blind Method; D005060:Europe; D005342:Fibrinolysis; D006293:Health Promotion; D006801:Humans; D007249:Inflammation; D007391:International Cooperation; D015337:Multicenter Studies as Topic / Q000379:methods / Q000706:statistics & numerical data; D009102:Multiple Organ Failure / Q000188:drug therapy / Q000209:etiology / Q000401:mortality; D011486:Protein C / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012107:Research Design; D012772:Shock, Septic / Q000188:drug therapy* / Q000401:mortality; D019851:Thrombophilia / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D014481:United States
D001779:Blood Coagulation Factors; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated