Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
"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.
干预措施: Blood sampling for psychoactive drugs dosage (Biological)
"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)
干预措施: Blood sampling for psychoactive drugs dosage (Biological)
结局指标
主要结局
Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups.
时间窗: 3 years
To evaluate if serious traumatic consequences are more important in the group of elderly patients with plasma overdoses of psychoactive drugs than in the "non-overdosed" group.
次要结局
- Relationship between the category of severity of the fall (according to the criteria of Schwenk et al, 2012) and the interactions highlighted in the prescription(3 years)
- Comparison between psychoactive drugs identified in the blood and expected prescriptions (entry prescription)(3 years)
- Relationship between the blood concentrations of psychoactive drugs and the occurrence of confusional syndrome assessed by the Confusion Assessment Method and/or neurocognitive disorders assessed by the Mini Mental State Evaluation.(3 years)
- Relationship between drug blood concentrations and severity of the fall, various states and functions studied during the geriatric consultation (dependence, mood, nutritional state, renal and liver function, presence of drug-drug interactions).(3 years)
- Evaluation of the severity of the fall (according to the criteria of Schwenk et al, 2012) with regard to a recent modification or not of the prescription (descriptive presentation of modification of dosage, addition ore deletion)(3 years)