Clinical Trial: Adverse Drug Reactions With Fatal Outcome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Adverse Drug Reactions With Fatal Outcome

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

Detailed Summary: The investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015
Sponsor: Germans Trias i Pujol Hospital

Current Primary Outcome: Incidence of drug-related deaths of all hospital admissions [ Time Frame: during the year 2015 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of drug-related deaths with the suspected drug started the previous week [ Time Frame: during the year 2015 ]
  • Number of drug-related deaths with drug interactions between suspected drugs [ Time Frame: during the year 2015 ]
  • Number of preventable drug-related deaths assessed by Schumock criteria [ Time Frame: during the year 2015 ]
  • Number of drug-related deaths with polypharmacy [ Time Frame: during the year 2015 ]
    Polypharmacy: when patient received >10 drugs
  • Number of drug-related deaths with autopsy [ Time Frame: during the year 2015 ]
  • Number of drug-related deaths in which the suspected drug had a contributive role [ Time Frame: during the year 2015 ]
  • 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 ]
  • Number of drug-related deaths presented during hospitalization [ Time Frame: during the year 2015 ]
  • Risk factors of drug-related deaths [ Time Frame: during the year 2015 ]
    risk factors assessed: age, sex, Charlson score, and hospitalization length
  • Incidence of drug-related deaths of all inpatients deaths [ Time Frame: during the year 2015. ]


Original Secondary Outcome: Same as current

Information By: Germans Trias i Pujol Hospital

Dates:
Date Received: July 13, 2016
Date Started: February 2016
Date Completion:
Last Updated: July 15, 2016
Last Verified: July 2016