Fall Clinical Trial - Relation Between Psychoactive Drugs Overdosage &

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Fall

Clinical Trial Details

NCT number	NCT05991037
Study type	Interventional
Source	University Hospital, Caen
Contact	Véronique Lelong-Boulouard, PhD
Phone	0231063341
Email	lelongboulouard-v@chu-caen.fr
Status	Not yet recruiting
Phase	N/A
Start date	September 2023
Completion date	October 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms