Characteristics of Spiking in Ghent: A Multicentric Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- In what type of places does spiking occur in Ghent
研究概览
简要总结
This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis.
Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent;
详细描述
This study aims at objectivating and characterizing the patients with alleged spiking in the city of Ghent.
Every patient who presents at one of the four (out of four) emergency departments of Ghent, with a suspicion of spiking (drink/food/needle-spiking included), will be offered to take part of this study.
The study entails a list of questions for the patient regarding demographics, recent own medication/drug/alcohol use and experienced symptoms; whilst the caregiver (doctor/nurse) completes a questionnaire regarding symptoms at time of presentation.
For a presentation within 48h after event, both blood and urine samples are requested from the patient. When presenting between 48h and 96h after the event, only urine samples are requested.
On this samples, IA and LC-GCMS according to the UNODOC standards ("Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts") to objectify exogenous products.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years
- •Patient self-reports suspicion of spiking OR there is a suspicion of spiking by physician, police, paramedics or patient's companions
- •willingness to provide urine and/or blood samples (depending on timing after event)
排除标准
- •Reporting more than 5 days after spiking
- •Unable to reliably complete the questionnaire (can be after clinical observation/recovery).
- •Not declaring proficiency in the language in which informed consent is offered (Dutch/English).
- •Not agreeing to the informed consent.
- •Do not consent to blood and urine collection and/or analysis.
- •There is a suspicion of Drug Facilitated Sexual Assault (to be referred to Care Center Sexual Violence, ZSG, where parallel study is ongoing).
结局指标
主要结局
In what type of places does spiking occur in Ghent
时间窗: 19 months
Location of spiking event
What is the type of product and mode of administration used in spiking
时间窗: 19 months
Defining type of products and mode of administration
What are patient characteristics of patients with spiking
时间窗: 19 months
Demographic features of the patients diagnosed with spiking
What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?
时间窗: 19 months
Number of patients presenting to the ED with spiking
次要结局
未报告次要终点