Delirium Related to Proton Pump Inhibitors Use

NCT ID: NCT05815550

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19081 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-09

Study Completion Date

2022-02-10

Brief Summary

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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

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Conditions

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Proton Pump Inhibitor Adverse Reaction Delirium Hyponatremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PPI users

PPI

Intervention Type DRUG

Use of PPI defined as PPI mentioned in the safety report

Interventions

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PPI

Use of PPI defined as PPI mentioned in the safety report

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PPI use
* Delirium mentioned in the safety report
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

References

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Decros A, Minoc EM, Lelong-Boulouard V, Chretien B, Meurant A, Alexandre J, Dolladille C, Villain C. Association between exposure to proton pump inhibitors and delirium: a descriptive and disproportionality analysis of VigiBase. BMJ Open. 2024 Oct 16;14(10):e081911. doi: 10.1136/bmjopen-2023-081911.

Reference Type DERIVED
PMID: 39414279 (View on PubMed)

Other Identifiers

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2646

Identifier Type: -

Identifier Source: org_study_id

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