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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2028-05-30

Brief Summary

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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.

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Detailed Description

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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

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Fall

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The severity of the fall will be assessed in the 400 patients included. The groups will be defined a posteriori, according to the results obtained for the psychoactive drug dosages.

Approximately 80 patients expected in the "overdosed" group matched to the same number of subjects on gender, age and cognition from the 320 subjects in the "non-overdosed" group to meet the primary objective at risk α = 5% and a power = 80%.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The groups will be constituted after the inclusions according to the results of the psychoactive drug blood concentration measures, so that Participants, Care Provider and Investigators will be blinded.

Study Groups

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"overdosed" group

The experimental group will be made up of falling patients recruited for whom at least one psychoactive drug has been measured in a concentration higher than the usual therapeutic ranges.

Group Type EXPERIMENTAL

Blood sampling for psychoactive drugs dosage

Intervention Type BIOLOGICAL

4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management

"non-overdosed" group

The control group will be made up of falling patients recruited for whom none of the psychoactive drugs have been measured in supra-therapeutic concentrations (therefore concentrations measured therapeutic or infra-therapeutic)

Group Type OTHER

Blood sampling for psychoactive drugs dosage

Intervention Type BIOLOGICAL

4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient (male, female) aged 75 and over admitted to the emergency room for a fall and for whom hospitalization (in geriatrics or not) after going to the emergency room is planned
* Patient consuming at least one psychoactive drug from the list provided in the protocol
* Patient able to move before hospitalization with or without technical assistance
* Patient who signed the consent
* Patient subject to the social security system

Exclusion Criteria

* Patient not requiring hospitalization after going to the emergency room
* Patient having fallen for more than 12 hours before inclusion in the study (time of sampling) \[risk of excessive elimination of certain drugs with short half-lives\]
* Parkinsonian patient or patient who has fallen following a convulsive attack
* Patient with a life-threatening prognosis in the very short term (state of shock, palliative care planned from the emergency room)
* Patient in wheelchair or bedridden
* Adult under legal protection, guardianship, curators
* Patient not understanding the French language

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No