Delirium Related to Proton Pump Inhibitors Use

March 24, 2025 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19081

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Caen University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The investigators describe the profile of patients who are reported in the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, as having experienced a delirium. In particular, the number of patients who use proton pomp inhibitors (PPIs), the number of patients who presented associated illnesses known to induce delirium, the number of patients who presented associated drug prescriptions known to induce delirium.

Description

Inclusion Criteria:

  • PPI use
  • Delirium mentioned in the safety report

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PPI users
Drug: PPI
Use of PPI defined as PPI mentioned in the safety report

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delirium occuring when using PPI
Time Frame: 09/02/2022
09/02/2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between PPI use and occurrence of delirium
Time Frame: 09/02/2022
Association assessed by performing a disproportionality analysis with adjustment on confounders
09/02/2022
Association between PPI use and occurrence of delirium and hyponatremia
Time Frame: 09/02/2022
Association assessed by performing a disproportionality analysis with adjustment on confounders
09/02/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2022

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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