NCT05991037

Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People

Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges. The aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.

Detailed description

Patients over the age of 75 with at least one psychoactive drugs in their usual treatment will be included in the study in order to assess the severity of their fall and to measure the concentrations of all psychoactive drugs identified in their blood samples. This study must include 400 patients over the age of 75 hospitalized for a fall in geriatrics or another department after going to the emergency room. Patients will be included in the study as soon as they go to the emergency room during which the blood samples will be taken and several data collected. The final inclusions and the consultations to collect the clinical and biological data essential to the achievement of the main and secondary objectives will then be carried out by a geriatrician in the patient's hospitalization department. Qualitative research and plasma assays of psychoactive drugs will be carried out by liquid phase chromatography coupled with a tandem mass spectrometer. The expected duration of the study will be 3 years.

Conditions

• Fall

Interventions

Type	Name	Description
BIOLOGICAL	Blood sampling for psychoactive drugs dosage	4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management

Timeline

• Start date: 2024-05-22
• Primary completion: 2027-05-30
• Completion: 2028-05-30
• First posted: 2023-08-14
• Last updated: 2025-07-25

Locations

1 site across 1 country: France