Epidemiology of Acute Self-poisoning in Emergency Services in France (EpiTox)

April 16, 2019 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients dispatched of admitted for acute self poisoning in emergency medical services and/or emergency departments

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of each drug class
Time Frame: 48h
48h

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

French Society of Emergency Medicine

Investigators

  • Principal Investigator: Maxime Maignan, MD MSc, Emergency department, CHU Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EpiTox

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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