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OpenTrials
Completed

NCT Number: NCT05815550

Delirium Related to Proton Pump Inhibitors Use

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PPI use
  • Delirium mentioned in the safety report

Treatment and study plan

PPI

Drug

Use of PPI defined as PPI mentioned in the safety report

Primary outcomes

  1. Delirium occuring when using PPI

    Time frame: 09/02/2022

Secondary outcomes

  1. Association between PPI use and occurrence of delirium

    Time frame: 09/02/2022

    Association assessed by performing a disproportionality analysis with adjustment on confounders

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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