Delirium Related to Proton Pump Inhibitors Use

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815550
• Other study ID #: 2646
• Status: Completed
• Start date: February 9, 2022
• Est. completion date: February 10, 2022

Study information

• Verified date: April 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19081
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PPI use
• Delirium mentioned in the safety report

Related Conditions & MeSH terms

• Delirium
• Hyponatremia
• Proton Pump Inhibitor Adverse Reaction

Intervention

Drug:
• PPI
Use of PPI defined as PPI mentioned in the safety report

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium occuring when using PPI		09/02/2022
Secondary	Association between PPI use and occurrence of delirium	Association assessed by performing a disproportionality analysis with adjustment on confounders	09/02/2022
Secondary	Association between PPI use and occurrence of delirium and hyponatremia	Association assessed by performing a disproportionality analysis with adjustment on confounders	09/02/2022