Overview

This trial is active, not recruiting.

Condition suicide attempts
Treatment no intervention
Sponsor University Hospital, Grenoble
Collaborator french society for emergency medicine
Start date March 2015
End date April 2015
Trial size 700 participants
Trial identifier NCT02518386, EpiTox

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Percentage of each drug class
time frame: 48h

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Evaluation of the Epidemiology and the Take Load of Voluntary Drug Intoxications by the Emergency Structures in France
Principal investigator Maxime Maignan, MD MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.