Do high blood levels of psychoactive drugs make falls worse in people 75 and older?
Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old
See if people 75 and older who have higher-than-usual blood levels of psychoactive drugs have more serious injuries after a fall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT05991037 on ClinicalTrials.gov |
What this trial studies
This study will enroll 400 patients aged 75 and over who are hospitalized after a fall and who take at least one psychoactive medication. Blood samples taken in the emergency room will be analyzed by liquid chromatography–tandem mass spectrometry to measure plasma concentrations of psychoactive drugs. Clinical and injury-severity data will be collected during the hospital stay by a geriatrician and used to compare the proportion of serious traumatic consequences between patients with plasma overdoses and those with concentrations in the usual therapeutic range. The study is expected to run for about three years at Caen University Hospital.
Who should consider this trial
Good fit: Ideal candidates are people aged 75 or older who were hospitalized after a fall, are taking at least one listed psychoactive drug, can give consent, and were mobile before admission.
Not a fit: People under 75, those not taking psychoactive drugs, patients who fell due to seizures or Parkinsonian causes, those not hospitalized, or those in imminent end-of-life care are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help doctors identify older patients at higher risk of severe fall injuries and guide safer prescribing or monitoring of psychoactive medications.
How similar studies have performed: Epidemiological studies have linked the use and number of psychoactive drugs to fall risk, but few prior studies have examined blood drug concentrations and fall severity, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen
- Caen University Hospital — Caen, France (Recruiting)
Study contacts
- Study coordinator: Véronique Lelong-Boulouard, PhD
- Email: lelongboulouard-v@chu-caen.fr
- Phone: 0231063341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.