Clinical trial NCT02518386: Epidemiology of Acute Self-poisoning in Emergency Services in France
Official title: Evaluation of the Epidemiology and the Take Load of Voluntary Drug Intoxications by the Emergency Structures in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide Attempts
Keywords: emergency department
epidemiology
prehospital care
dispatch
acute self poisoning
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: French Society of Emergency Medicine
First posted: 2015-08-07
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients dispatched of admitted for acute self poisoning in emergency medical services and/or emergency departments

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of each drug class
timeFrame: 48h
Secondary outcomes:
measure: odds ratio of drug classes according to sexe and age
timeFrame: 48h
measure: number of participants with poisoning incident
timeFrame: 48h
measure: prehospital and inhospital mortality
timeFrame: 30 days
measure: percentage of each antidotal treatment
timeFrame: 48h
measure: mobile intensive care unit (percentage) dispatch
timeFrame: 30 days
measure: Age according to drug classes ingestion
timeFrame: 48h
measure: Gender according to drug classes ingestion
timeFrame: 48h
measure: Time (median) of admission according to drug classes ingestion
timeFrame: 48h
measure: Time (median) of admission according unit of admission
timeFrame: 48h
measure: Mortality according to drug class ingestion
timeFrame: 30 days
measure: ICU admission according to drug class ingestion
timeFrame: 30 days
measure: icu admission (percentage)
timeFrame: 48h
measure: percentage of errors according to the Grenoble clinical decision rule
timeFrame: 30 days
measure: multivariate analysis to describe factors associated with ICU admission
timeFrame: 30 days
measure: multivariate analysis to describe factors associated with mobile intensive care unit dispatch
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Emergency department, CHU Grenoble
name: Maxime Maignan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: