Iatrogenic DiseaseEIUNCT03960398
Incidence of Iatrogenic Diseases on Hospital's Emergency Consultations
An observational study of Iatrogenic Disease, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial summary
French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050. The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iatrogenic Disease
- What is being tested?
- Iatrogenic disease impact on emergency consultations
- How many people
- 2,500 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jun 2019to 9 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adults living in the south-east of France and consulting the emergency department of Toulon - La Seyne sur Mer public hospital
Who may be able to join
- Man or woman over 18 years old
- Consultation in emergency department of Sainte Musse or La Seyne-sur-Mer hospital between 21st june 2018 and 22nd september 2018 included
- Consultation of the patient in emergency department during the 10 day random draw of the research (from 00h01 to 23h59)
- Consultation in emergency department because of a iatrogenic reason
Who cannot join
- Dead patients
- Patient's opposition
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer
La Seyne-sur-Mer, Var, 83500
Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer
Toulon, Var, 83100
About this study
Official title: Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018
French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050.
The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions.
Finally, according to Health Ministry, the number of emergency department consultations doubled from 1996 to 2016.
Consequently, it is interesting to study the impact of drug iatrogenic effects on emergency consultations.
It would help to prevent these adverse drug reactions as we prescribe those drugs : First, do not harm.
Read the detailed description
This will be a retrospective study.
The number of patients will be defined by the number of visits during a random draw of 10 emergency department consultation days between 21st June 2018 and 22nd September 2018 in Toulon - La Seyne sur Mer public hospital.
There are between 100 and 300 emergency department consultations per day in this hospital so the estimated number of patients will be between 1000 and 3000.
Every patient who came to hospital for a consultation in emergency department during this period of time will be included in the study except those who expressed their opposition to their data collection and treatment.
Each patient will be anonymized with a code defined as follows : N(ame) L(ast name) 001 (chronological inclusion number)
Information of the patients involved in adverse drug reactions will be extracted and a description of this patient sample will be made.
- Conditions
- Iatrogenic Disease
- Being tested
- Iatrogenic disease impact on emergency consultations
- Keywords
- iatrogenic, emergency, incidence, adverse drug reaction
- Medical subject headings
- Iatrogenic Disease, Emergencies, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iatrogenic disease impact on emergency consultationsDrug
Determination of the proportion of emergency consultations linked to iatrogenic diseases
| Study group | Role | What they receive |
|---|---|---|
| Patients concerned by iatrogenic diseases | Patients living in the South-East of France and consulting in the emergency department of Toulon La Seyne sur Mer hospital for iatrogenic diseases Receives: Drug: Iatrogenic disease impact on emergency consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients coming to emergency department because of an adverse drug reaction
We will study each case and determine whether the consultation in the emergency department is due to adverse drug reaction or not.Number of patients having an emergency department consultation because of an adverse drug reaction divided by the total number of patients having an emergency department consultation during the same period of time.
Measured: 10 days (chosen at random between 21st June and 22nd September 2018)
Secondary outcomes (4)
Average of patient age among the patients consulting because of an adverse drug reaction
Average and standard deviation of patient age among the patients consulting in emergency department because of an adverse drug reaction.
Measured: 10 days
Proportion of male and female patients consulting because of an adverse drug reaction
Number of male and female patients consulting in emergency department because of an adverse drug reaction divided by the total number of patients consulting in emergency department because of an adverse drug reaction.
Measured: 10 days
Number of treatments administered to patients who consult because of an adverse drug reaction
Number of treatments patients were taking when they arrived in emergency department for a consultation because of an adverse drug reaction
Measured: 1 day
Frequency of the drugs leading to a consultation in emergency department because of an adverse drug reaction
For each drug leading, during the 10 chosen days, to a consultation because of an adverse reaction, number of times when this drug was at the origin of a consultation
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start28 Jun 2019
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiziana PLATINO, MD, Study director, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960398
- Sponsor's protocol ID
- 2019-CHITS-02
- Acronym
- EIU
- Status last verified
- Nov 2019
- First submitted
- 21 May 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018
- ClinicalTrials.gov ID
- NCT03960398
- Acronym / sponsor ID
- EIU / 2019-CHITS-02
- Conditions
- Iatrogenic Disease
- Keywords
- iatrogenic, emergency, incidence, adverse drug reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 23 May 2019 (actual)
- 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.
French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050.
The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions.
Finally, according to Health Ministry, the number of emergency department consultations doubled from 1996 to 2016.
Consequently, it is interesting to study the impact of drug iatrogenic effects on emergency consultations.
It would help to prevent these adverse drug reactions as we prescribe those drugs : First, do not harm.
Detailed description
This will be a retrospective study.
The number of patients will be defined by the number of visits during a random draw of 10 emergency department consultation days between 21st June 2018 and 22nd September 2018 in Toulon - La Seyne sur Mer public hospital.
There are between 100 and 300 emergency department consultations per day in this hospital so the estimated number of patients will be between 1000 and 3000.
Every patient who came to hospital for a consultation in emergency department during this period of time will be included in the study except those who expressed their opposition to their data collection and treatment.
Each patient will be anonymized with a code defined as follows : N(ame) L(ast name) 001 (chronological inclusion number)
Information of the patients involved in adverse drug reactions will be extracted and a description of this patient sample will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients concerned by iatrogenic diseases | – | Drug: Iatrogenic disease impact on emergency consultationsPatients living in the South-East of France and consulting in the emergency department of Toulon La Seyne sur Mer hospital for iatrogenic diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adults living in the south-east of France and consulting the emergency department of Toulon - La Seyne sur Mer public hospital
Key inclusion criteria (4 listed)
- Man or woman over 18 years old
- Consultation in emergency department of Sainte Musse or La Seyne-sur-Mer hospital between 21st june 2018 and 22nd september 2018 included
- Consultation of the patient in emergency department during the 10 day random draw of the research (from 00h01 to 23h59)
- Consultation in emergency department because of a iatrogenic reason
Key exclusion criteria (2 listed)
- Dead patients
- Patient's opposition
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 |
|---|---|---|
| Iatrogenic disease impact on emergency consultationsDetermination of the proportion of emergency consultations linked to iatrogenic diseases | Drug | Patients concerned by iatrogenic diseases |
Primary outcome
Proportion of patients coming to emergency department because of an adverse drug reaction
Time frame: 10 days (chosen at random between 21st June and 22nd September 2018)
We will study each case and determine whether the consultation in the emergency department is due to adverse drug reaction or not.Number of patients having an emergency department consultation because of an adverse drug reaction divided by the total number of patients having an emergency department consultation during the same period of time.
4 secondary outcomes
Average of patient age among the patients consulting because of an adverse drug reaction
Time frame: 10 days
Proportion of male and female patients consulting because of an adverse drug reaction
Time frame: 10 days
Number of treatments administered to patients who consult because of an adverse drug reaction
Time frame: 1 day
Frequency of the drugs leading to a consultation in emergency department because of an adverse drug reaction
Time frame: 10 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 29 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Tiziana PLATINO, MD study director
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Disease, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
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 4 inclusion and 2 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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Proportion of patients coming to emergency department because of an adverse drug reaction (time frame: 10 days (chosen at random between 21st June and 22nd September 2018)). 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 29 Nov 2019.