Suicide AttemptsEpiToxNCT02518386
Epidemiology of Acute Self-poisoning in Emergency Services in France
An observational study of Suicide Attempts, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide Attempts
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2016
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients dispatched of admitted for acute self poisoning in emergency medical services and/or emergency departments
Who may be able to join
- acute self poisoning defined as the intentional intake (oral, nasal, injection etc.) of medicines during the 24h before first medical contact
Who cannot join
- cardiac arrest at first medical contact (dispatch or physician)
- acute self poisoning without any medication intake
- non intentional poisoning
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide Attempts
- Being tested
- No intervention
- Keywords
- emergency department, epidemiology, prehospital care, dispatch, acute self poisoning
- Medical subject headings
- Suicide, Attempted, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is planned
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of each drug class
Measured: 48h
Secondary outcomes (15)
odds ratio of drug classes according to sexe and age
Measured: 48h
number of participants with poisoning incident
Measured: 48h
prehospital and inhospital mortality
Measured: 30 days
percentage of each antidotal treatment
Measured: 48h
mobile intensive care unit (percentage) dispatch
Measured: 30 days
Age according to drug classes ingestion
Median age compared according drug classes ingestion
Measured: 48h
Gender according to drug classes ingestion
Pourcentage of gender compared according drug classes ingestion
Measured: 48h
Time (median) of admission according to drug classes ingestion
Measured: 48h
Time (median) of admission according unit of admission
Measured: 48h
Mortality according to drug class ingestion
Measured: 30 days
ICU admission according to drug class ingestion
Measured: 30 days
icu admission (percentage)
Measured: 48h
percentage of errors according to the Grenoble clinical decision rule
Measured: 30 days
multivariate analysis to describe factors associated with ICU admission
Measured: 30 days
multivariate analysis to describe factors associated with mobile intensive care unit dispatch
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide AttemptsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Emergency Medicine
- Responsible party
- Sponsor
- Investigators
- Maxime Maignan, MD MSc, Principal investigator, Emergency department, CHU Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518386
- Sponsor's protocol ID
- EpiTox
- Acronym
- EpiTox
- Status last verified
- Apr 2019
- First submitted
- 24 Feb 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Epidemiology and the Take Load of Voluntary Drug Intoxications by the Emergency Structures in France
- ClinicalTrials.gov ID
- NCT02518386
- Acronym / sponsor ID
- EpiTox / EpiTox
- Conditions
- Suicide Attempts
- Keywords
- emergency department, epidemiology, prehospital care, dispatch, acute self poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- French Society of Emergency Medicine
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients dispatched of admitted for acute self poisoning in emergency medical services and/or emergency departments
Key inclusion criteria (1 listed)
- acute self poisoning defined as the intentional intake (oral, nasal, injection etc.) of medicines during the 24h before first medical contact
Key exclusion criteria (3 listed)
- cardiac arrest at first medical contact (dispatch or physician)
- acute self poisoning without any medication intake
- non intentional poisoning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention is planned | Other | – |
Primary outcome
Percentage of each drug class
Time frame: 48h
15 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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DBT Skills Groups for Veterans at High Risk for Suicide Attempt
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Expanding Access to Evidence-Based Suicide Risk Assessment and Intervention in a Crisis Stabilization Setting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Maignan, MD MSc principal investigator
Emergency department, CHU Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide Attempts, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of each drug class (time frame: 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.