Skip to content

Delirium Related to Proton Pump Inhibitors Use

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05815550
Enrollment
19081
Registered
2023-04-18
Start date
2022-02-09
Completion date
2022-02-10
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proton Pump Inhibitor Adverse Reaction, Delirium, Hyponatremia

Keywords

Proton Pump Inhibitor, Delirium, Drug safety, Hyponatremia

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.

Interventions

DRUGPPI

Use of PPI defined as PPI mentioned in the safety report

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* PPI use * Delirium mentioned in the safety report

Design outcomes

Primary

MeasureTime frame
Delirium occuring when using PPI09/02/2022

Secondary

MeasureTime frameDescription
Association between PPI use and occurrence of delirium09/02/2022Association assessed by performing a disproportionality analysis with adjustment on confounders
Association between PPI use and occurrence of delirium and hyponatremia09/02/2022Association assessed by performing a disproportionality analysis with adjustment on confounders

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026