- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03726632
Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux (GERIATOX)
Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux Over 5 Months
Elderly is often associated with social, physiological and psychic changes. However, no study has examined accidental poisoning-induced changes.
The objective of the study is to identify and analyze the various causes of potentially toxic accidental exposure of the elderly to determine preventable causes and propose prevention strategies.
Study Overview
Status
Conditions
Detailed Description
Elderly is often associated with social, physiological and psychic changes. Many studies tried to demonstrate their influence in the genesis of pathological events such as falls or suicide of the elderly but none on the genesis of accidental poisoning.
However, poisoning in this age group is frequent and sometimes severe. In order to improve care of the elderly, it seems necessary to focus on potential toxic accidental exposure.
For this, Poison Control Centre of the University Hospital of Bordeaux has identified the causes over a period of 5 months (from 01 March to 31 July 2017) from calls to the centre.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Bordeaux, France
- Centre Anti Poision du CHU de Bordeaux
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All subjects aged 65 and over,
- Victims of accidental exposure regardless of the agent (drug, household product, plant ...)
- Victims of voluntary exposure (out of suicidal behavior)
- And for which a call (notice, report) to the Poison Control Centre of Bordeaux has been recorded.
- Calling dates between March 1st and July 31st, even if the exhibition is prior to March 1st, 2017).
Exclusion Criteria:
- Suicide
- Calls for inquiries
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nature of the agent
Time Frame: Baseline
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The nature of the agent has to be chosen among (1 choice only): drug, chemical, household product, DIY product, phytosanitary product, gas, plant, foreign body, food
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circumstance of the event
Time Frame: Baseline
|
The circumstance of the event has to be chosen among (1 choice only): accidental / voluntary
|
Baseline
|
|
Exposition route of exposure
Time Frame: Baseline
|
The exposition route of exposure has to be chosen among (1 choice only): ingestion, eyepiece, dermal, inhalation or multiple routes
|
Baseline
|
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symptoms
Time Frame: Baseline
|
Number / Nature
|
Baseline
|
|
Poisoning Severity
Time Frame: Baseline
|
The poisoning severity is evaluated using the Poisoning Severity Scale (PSS score).
Severity grades: None (No symptoms or signs related to poisoning); MINOR (Mild, transient and spontaneously resolving symptoms); MODERATE (Pronounced or prolonged symptoms); SEVERE (Severe or life-threatening symptoms); DEATH
|
Baseline
|
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Death
Time Frame: Baseline
|
death before the call
|
Baseline
|
|
Frailty status
Time Frame: Baseline
|
The frailty status is calculated from the following factors: sensory disturbance, cognitive and/or neurological disorder, psychiatric disorder, autonomy / dependence, concomittant treatments
|
Baseline
|
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packaging of the agent
Time Frame: Baseline
|
The packaging of the agent has to be chosen among (1 choice only): solid, liquid, gaseous, powder and if drug: tablet, drops, syrup, patch, injectable
|
Baseline
|
|
Concomittant treatment
Time Frame: Baseline
|
Number of prescription drugs
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2017/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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