Esomeprazole to Reduce Organ Failure in Sepsis

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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 safety profile. Carta and Rubartelli (IRCCS San Martino - Genova) have recently reported that PPI, such as esomeprazole, inhibit TNF-alfa and IL-1ß secretion. Moreover, they showed that a single administration of PPI protects mice from endotoxic shock with no adverse effects. PPI-SEPSIS is a randomized, double blind, controlled against placebo clinical trial to test if high-doses esomeprazole in septic patients reduces the severity of organs failure.

In parallel, the investigators will evaluate ex vivo in monocytes from septic patients: redox state and response to inflammatory stimuli; ATP release; metabolic changes and pH; cytokine production; the effects of PPI on these parameters.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università Vita-Salute San Raffaele
• Collaborator: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Treatments: Esomeprazole; Proton Pump Inhibitors

Criteria

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