Delirium Related to Proton Pump Inhibitors Use

Completed

• Conditions: Hyponatremia; Delirium; Proton Pump Inhibitor Adverse Reaction
• Interventions: Drug: PPI

• Registration Number: NCT05815550
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-09
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2023-04
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19081

Inclusion Criteria

• PPI use
• Delirium mentioned in the safety report

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PPI users	PPI	-

Primary Outcome Measures

Name	Time	Method
Delirium occuring when using PPI	09/02/2022

Secondary Outcome Measures

Name	Time	Method
Association between PPI use and occurrence of delirium	09/02/2022	Association assessed by performing a disproportionality analysis with adjustment on confounders
Association between PPI use and occurrence of delirium and hyponatremia	09/02/2022	Association assessed by performing a disproportionality analysis with adjustment on confounders

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France