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临床试验/NCT02518386
NCT02518386已完成不适用

Evaluation of the Epidemiology and the Take Load of Voluntary Drug Intoxications by the Emergency Structures in France

University Hospital, Grenoble0 个研究点目标入组 700 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
主要终点
Percentage of each drug class

研究概览

简要总结

Acute self poisoning is a leading cause of suicide attempts and leads to frequent emergency department visits. However, the exact epidemiology of acute self poisoning is not known. The description of the clinical pathway and the characteristics of patients with acute self poisoning could lead to an improvement in emergency care.

The Investigators will conduct a 48h observational study in emergency services in France. Investigators primary objective is to gathered epidemiological clinical and treatment data during emergency dispatch, prehospital care and inhospital emergency care.

详细描述

Acute self poisoned patients will be prospectively and anonymously recruited by emergency physicians in charge during two days. Acute self poisoning is define as follow: intentional medicine intake in the 24h hours before emergency department admission.

Epidemiological, clinical, toxicological and treatment data will be gathered. Outcome of patient will be prospectively assessed at 30days.

All data will be transmitted to the principal investigators. Then, 20% of the data will be monitored by an independent committee.

Exhaustivity will be retrospectively assessed by the number of inclusions in 10 emergency centers divided by the total number of possible inclusions in these centers.

Finally, an independent statistician will be in charge of the analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • acute self poisoning defined as the intentional intake (oral, nasal, injection etc.) of medicines during the 24h before first medical contact

排除标准

  • cardiac arrest at first medical contact (dispatch or physician)
  • acute self poisoning without any medication intake
  • non intentional poisoning

结局指标

主要结局

Percentage of each drug class

时间窗: 48h

次要结局

  • percentage of errors according to the Grenoble clinical decision rule(30 days)
  • multivariate analysis to describe factors associated with ICU admission(30 days)
  • multivariate analysis to describe factors associated with mobile intensive care unit dispatch(30 days)
  • odds ratio of drug classes according to sexe and age(48h)
  • number of participants with poisoning incident(48h)
  • prehospital and inhospital mortality(30 days)
  • percentage of each antidotal treatment(48h)
  • Time (median) of admission according unit of admission(48h)
  • mobile intensive care unit (percentage) dispatch(30 days)
  • Age according to drug classes ingestion(48h)
  • Gender according to drug classes ingestion(48h)
  • Time (median) of admission according to drug classes ingestion(48h)
  • Mortality according to drug class ingestion(30 days)
  • ICU admission according to drug class ingestion(30 days)
  • icu admission (percentage)(48h)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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