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OpenTrials
Completed

NCT Number: NCT02838212

Adverse Drug Reactions With Fatal Outcome

The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

The investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • inpatients deaths and drug-related deaths.

Exclusion criteria

  • death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.

Treatment and study plan

adverse drug reaction

Drug

drug-related death

Other names: side effect

Primary outcomes

  1. Incidence of drug-related deaths of all hospital admissions

    Time frame: during the year 2015

Secondary outcomes

  1. Number of drug-related deaths with the suspected drug started the previous week

    Time frame: during the year 2015

  2. Number of drug-related deaths with drug interactions between suspected drugs

    Time frame: during the year 2015

  3. Number of preventable drug-related deaths assessed by Schumock criteria

    Time frame: during the year 2015

  4. Number of drug-related deaths with polypharmacy

    Time frame: during the year 2015

    Polypharmacy: when patient received >10 drugs

  5. Number of drug-related deaths with autopsy

    Time frame: during the year 2015

  6. Number of drug-related deaths in which the suspected drug had a contributive role

    Time frame: during the year 2015

  7. Number of drug-related deaths with "certain" or "probable" categories assessed by World Health Organization (WHO) criteria and Naranjo algorithm

    Time frame: during the year 2015

  8. Number of drug-related deaths presented during hospitalization

    Time frame: during the year 2015

  9. Risk factors of drug-related deaths

    Time frame: during the year 2015

    risk factors assessed: age, sex, Charlson score, and hospitalization length

  10. Incidence of drug-related deaths of all inpatients deaths

    Time frame: during the year 2015.

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2016
Registry last updated
Jul 20, 2016

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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