Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Early predictors of hepatic injury
研究概览
简要总结
A: Early predictors of hepatic injury after suicide attempt with acetaminophen:
To explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and hepatic injury, 2) the relevance of the early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the presence/absence of illness prior to the suicide attempt and hepatic injury.
B: Characteristics, social behaviour, trends and risk factors:
- To explore the relationship between children admitted to a paediatric department as a result of suicide attempts with acetaminophen and their parents and friends. 2. To determine the extent to which the children had attempted to speak to their parents or other adults about their problems before their suicide attempts. 3. To determine the prevalence of self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these suicide attempts.
C: Establishment of the expression of cytochrome P450 in a pediatric including the age-adjusted activities.
Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab.
There will be categorized three groups for comparison:
- An age-appropriate background population (approximately 200 patients)
- Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)
- Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8-18 years-old, who tried to commit suicide with acetaminophen.
- •Children are only included if they have answered all our standard questions.
排除标准
- •Children with known liver disease prior to the suicide attempt.
- •If a child have several suicide attempts during the inclusion-period, only the 1st will be included.
- •Suicide attempts with other agents than acetaminophen.
- •Children taking medication that enhance the induction of the cytochrome P450 system, increase the production of toxic metabolites, and aggravate the hepatic injury, such as ethanol, rifampin, isoniazid, barbiturates, and carbamazepine, will be excluded.
结局指标
主要结局
Early predictors of hepatic injury
时间窗: 2 years
1) To identify early clinical and biochemical predictors of hepatoxicity in children and adolescents after the ingestion of a single acetaminophen overdose as a part of a suicide attempt e.g. pre-hospital vomiting, in-hospital vomiting, stomach pains, latency time before NAC treatment, illness prior to the suicide attempt. The initial and maximum levels of the following biochemical parameters are registered from the electronic biochemistry files of each patient: gluthathione (GLU), basic phosphatase (BP), INR, ALT, AST, and s-acetaminophen.
次要结局
- Expression of CYP 1A2 in a pediatric population(2 years)
- Characteristics, social behaviour, trends and risk factors(2 years)
研究者
Rikke Hedeland
MD
Hillerod Hospital, Denmark