NCT05815550

Delirium Related to Proton Pump Inhibitors Use

Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19,081 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proton Pump Inhibitor Adverse Reaction
• Delirium
• Hyponatremia

Interventions

Type	Name	Description
DRUG	PPI	Use of PPI defined as PPI mentioned in the safety report

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2023-04-18
• Last updated: 2025-03-26

Locations

1 site across 1 country: France