NCT05991037 Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People
| NCT ID | NCT05991037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Fall |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-05-22 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Véronique Lelong-Boulouard, PhD
STUDY DIRECTOR
Caen Normandie Universitary Hospital Center
Frequently Asked Questions
Who can join the NCT05991037 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Fall. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05991037 currently recruiting?
Yes, NCT05991037 is actively recruiting participants. Contact the research team at lelongboulouard-v@chu-caen.fr for enrollment information.
Where is the NCT05991037 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05991037 clinical trial?
NCT05991037 is sponsored by University Hospital, Caen. The principal investigator is Véronique Lelong-Boulouard, PhD at Caen Normandie Universitary Hospital Center. The trial plans to enroll 400 participants.