NCT02518386

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

February 24, 2015

Last Update Submit

April 16, 2019

Conditions

Suicide Attempts

Keywords

emergency departmentepidemiologyprehospital caredispatchacute self poisoning

Outcome Measures

Primary Outcomes (1)

  • Percentage of each drug class

    48h

Secondary Outcomes (15)

  • 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

  • mobile intensive care unit (percentage) dispatch

    30 days

  • +10 more secondary outcomes

Interventions

No interventionOTHER

No intervention is planned

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Suicide, AttemptedEmergencies

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maxime Maignan, MD MSc

    Emergency department, CHU Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

August 7, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

June 1, 2016

Last Updated

April 17, 2019

Record last verified: 2019-04