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OpenTrials
Completed

NCT Number: NCT03960398

Incidence of Iatrogenic Diseases on Hospital's Emergency Consultations

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.

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Key information

Conditions

Iatrogenic Disease Chemically-Induced Disorders Disease Attributes Drug-Related Side Effects and Adverse Reactions Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer, La Seyne-sur-Mer, Var, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Dead patients
  • Patient's opposition

Treatment and study plan

Iatrogenic disease impact on emergency consultations

Drug

Determination of the proportion of emergency consultations linked to iatrogenic diseases

Primary outcomes

  1. 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.

Secondary outcomes

  1. Average of patient age among the patients consulting because of an adverse drug reaction

    Time frame: 10 days

    Average and standard deviation of patient age among the patients consulting in emergency department because of an adverse drug reaction.

  2. Proportion of male and female patients consulting because of an adverse drug reaction

    Time frame: 10 days

    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.

  3. Number of treatments administered to patients who consult because of an adverse drug reaction

    Time frame: 1 day

    Number of treatments patients were taking when they arrived in emergency department for a consultation because of an adverse drug reaction

  4. Frequency of the drugs leading to a consultation in emergency department because of an adverse drug reaction

    Time frame: 10 days

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018

Acronym: EIU

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 23, 2019
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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