Esomeprazole to Reduce Organ Failure in Sepsis (PPI-SEPSIS)
Sepsis, Septic Shock
About this trial
This is an interventional treatment trial for Sepsis focused on measuring proton pump inhibitor, esomeprazole, sepsis, septic shock, organ failure, SOFA, mortality
Eligibility Criteria
Inclusion Criteria:
- Age β₯ 18 years old
- Admitted to intensive care unit or emergency department
- Sepsis or septic shock
- Able to express informed consent. For unconscious patients, current laws will be applied as requested by Ethical Committee.
Exclusion Criteria
- Able to express informed consent and deny it
- Known allergy or intolerance to study drug
- Little chance of survival, as defined by a SAPS II score more than 65 point
- Concomitant acquired immunodeficiency syndrome
- On immunosuppressant or long-term corticosteroid therapy
- Receiving lifesaving drugs known to have a strong interference with esomeprazole
- Sepsis or septic shock since over 36 hours
- Severe hepatic dysfunction
- Pregnant or breastfeeding
Sites / Locations
- Policlinico Univeristario Campus Bio-MedicoRecruiting
- IRCCS San Martino Istitute
- Humanitas Clinical InstituteRecruiting
- IRCCS San Raffaele Scientific InstituteRecruiting
- A.O.U. Mater DominiRecruiting
- Azienda Ospedaliera UniversitariaRecruiting
- USSL 10 VenetoRecruiting
- Ospedale Maggiore di LodiRecruiting
- Ospedale di MeranoRecruiting
- UniversitΓ degli Studi della Campania "Luigi Vanvitelli"Recruiting
- AOU PisanaRecruiting
- AOU PisanaRecruiting
- A.O.R San CarloRecruiting
- Azienda Ospedaliera San Giovanni Battista Molinette di Torino
- Ospedale Santa Maria della MisericordiaRecruiting
- Astana Medical UniversityRecruiting
- Federal Clinical & Research Center for Reanimatology and RehabilitationRecruiting
- Negovskiy Reanimatology Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Esomeprazole
Placebo
Patients randomized to Esomeprazole Group will receive a bolus of 160 mg of esomeprazole (diluted in 100 ml of 0.9% sodium chloride for intravenous use and administered over 60 minutes) and an intravenous infusion of 12 mg/hr (diluted in 0.9% sodium chloride at a concentration of 8 mg/ml will be injected at a rate of 1.5 ml/hr) for 72 hours .
Patients randomized to Placebo Group will receive a bolus of 100 ml of 0.9% sodium chloride for intravenous use administered over 60 minutes with no active principle and an intravenous infusion of 0.9% sodium chloride at a rate of 1.5 ml/hr with no active principle for 72 hours .