Delirium Related to Proton Pump Inhibitors Use

NCT05815550 | Completed

• 1 other identifier: 2646
• Study Type: observational
• Target: 19,081
• Locations: 1 country
• Sites: 1

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.

Conditions

Proton Pump Inhibitor Adverse Reaction; Delirium; Hyponatremia

Keywords

Proton Pump Inhibitor; Delirium; Drug safety; Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Delirium occuring when using PPI

  09/02/2022

Secondary Outcomes (2)

• Association between PPI use and occurrence of delirium

  09/02/2022

• Association between PPI use and occurrence of delirium and hyponatremia

  09/02/2022

Study Arms (1)

PPI users

Drug: PPI

Interventions

PPI DRUG

Use of PPI defined as PPI mentioned in the safety report

PPI users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• PPI use
• Delirium mentioned in the safety report

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

Related Publications (1)

• 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.

  PMID: 39414279 DERIVED

MeSH Terms

Conditions

Delirium; Hyponatremia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: February 9, 2022
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: March 26, 2025

Record last verified: 2023-04

Locations

FR (1)