Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815550
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2023-04-04
Brief Title:
Delirium Related to Proton Pump Inhibitors Use
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Association Between Delirium and Use of Proton Pump Inhibitors Analysis of the Global Pharmacovigilance Database
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
Delirium is a frequent and severe condition especially in old adults Its occurrence is due to a drug in 30 of cases In 2009 the French national health authority Haute Autorité de Santé mentioned proton pump inhibitors PPIs among the drugs causing delirium Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion However a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use In 2016 a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium
Evidence linking delirium and PPI use is thus scarce By using data from the pharmacovigilance database of the World Health Organization WHO the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved and to evaluate the association between PPI use and delirium and the impact of hyponatremia in this association by performing a disproportionality analysis
Evidence linking delirium and PPI use is thus scarce By using data from the pharmacovigilance database of the World Health Organization WHO the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved and to evaluate the association between PPI use and delirium and the impact of hyponatremia in this association by performing a disproportionality analysis
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?:
None
Is an FDA AA801 Violation?:
None