Status:
COMPLETED
Esomeprazole to Reduce Organ Failure in Sepsis
Lead Sponsor:
Università Vita-Salute San Raffaele
Collaborating Sponsors:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Sepsis is a severe disease with a high mortality rate and lack of efficacious therapies. Proton pump inhibitors (PPI) are drugs widely used to inhibit acid secretion by gastric cells and with a high s...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 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
Exclusion
Key Trial Info
Start Date :
January 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03452865
Start Date
January 28 2020
End Date
August 21 2023
Last Update
January 19 2024
Active Locations (17)
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1
Policlinico Univeristario Campus Bio-Medico
Rome, Lazio, Italy
2
IRCCS San Martino Istitute
Genoa, Liguria, Italy
3
Humanitas Clinical Institute
Rozzano, Lombardy, Italy, 20100
4
IRCCS San Raffaele Scientific Institute
Milan, MI, Italy, 20132