Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03452865
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2018-02-26
Brief Title:
Esomeprazole to Reduce Organ Failure in Sepsis
Sponsor:
Università Vita-Salute San Raffaele
Organization:
Università Vita-Salute San Raffaele
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPI-SEPSIS
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000488-98 | EUDRACT_NUMBER | None | None |