Epidemiology of Acute Self-poisoning in Emergency Services in France

Suicide Attempts Clinical Trial

— EpiTox  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518386
• Other study ID #: EpiTox
• Status: Completed
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Suicide
• Suicide Attempts
• Suicide, Attempted

Intervention

Other:
• No intervention
No intervention is planned

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	French Society of Emergency Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of each drug class		48h
Secondary	odds ratio of drug classes according to sexe and age		48h
Secondary	number of participants with poisoning incident		48h
Secondary	prehospital and inhospital mortality		30 days
Secondary	percentage of each antidotal treatment		48h
Secondary	mobile intensive care unit (percentage) dispatch		30 days
Secondary	Age according to drug classes ingestion	Median age compared according drug classes ingestion	48h
Secondary	Gender according to drug classes ingestion	Pourcentage of gender compared according drug classes ingestion	48h
Secondary	Time (median) of admission according to drug classes ingestion		48h
Secondary	Time (median) of admission according unit of admission		48h
Secondary	Mortality according to drug class ingestion		30 days
Secondary	ICU admission according to drug class ingestion		30 days
Secondary	icu admission (percentage)		48h
Secondary	percentage of errors according to the Grenoble clinical decision rule		30 days
Secondary	multivariate analysis to describe factors associated with ICU admission		30 days
Secondary	multivariate analysis to describe factors associated with mobile intensive care unit dispatch		30 days