Proton pump inhibitors (PPI) as a new strategy for therapy in sepsis: clinical trial to reduce severity of organ failure and in vitro experiments to search specific hallmarks in monocytes from septic patients and to characterize the mechanism of action of PPI (PPI-SEPSIS) - PPI-Sepsis Trial

OSPEDALE SAN RAFFAELE0 个研究点目标入组 300 人开始时间: 2021年1月7日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•1.Age = 18 years old
•2.Admitted to intensive care unit or emergency department
•3.Sepsis or septic shock¿(Sepsis defined as acute change in total SOFA score=2 points consequent to the infection. The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction. Septic shock defined as sepsis plus persisting hypotension requiring vasopressors to maintain MAP =65mmHg and having a serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation)
•4.Able to express informed consent as requested by Ethical Committee
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1.Able to express informed consent and deny it
•2.Known allergy or intolerance to study drug
•3.Little chance of survival, as defined by a SAPS II score more than 65 point¿
•4.Concomitant acquired immunodeficiency syndrome (AIDS, Stage 3 HIV infection according to CDC)
•5.On immunosuppressant or long-term corticosteroid therapy (more than 0.5 mg/kg/day of prednisone or equivalent for over 30 days)
•6.Receiving lifesaving drugs known to have a strong interference with esomeprazole
•7.Sepsis or septic shock since over 36 hours¿
•8.Severe hepatic dysfunction
•9.Pregnant or breastfeeding

发起方

OSPEDALE SAN RAFFAELE