Adverse Drug Reactions With Fatal Outcome

Adverse Drug Reaction Clinical Trial

Official title:

Adverse Drug Reactions With Fatal Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838212
• Other study ID #: RAM-MORT 2015
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: July 15, 2016
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1135
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Drug-Related Side Effects and Adverse Reactions

Intervention

Drug:
• adverse drug reaction
drug-related death

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of drug-related deaths of all hospital admissions		during the year 2015	Yes
Secondary	Number of drug-related deaths with the suspected drug started the previous week		during the year 2015	Yes
Secondary	Number of drug-related deaths with drug interactions between suspected drugs		during the year 2015	Yes
Secondary	Number of preventable drug-related deaths assessed by Schumock criteria		during the year 2015	Yes
Secondary	Number of drug-related deaths with polypharmacy	Polypharmacy: when patient received >10 drugs	during the year 2015	Yes
Secondary	Number of drug-related deaths with autopsy		during the year 2015	Yes
Secondary	Number of drug-related deaths in which the suspected drug had a contributive role		during the year 2015	Yes
Secondary	Number of drug-related deaths with "certain" or "probable" categories assessed by World Health Organization (WHO) criteria and Naranjo algorithm		during the year 2015	Yes
Secondary	Number of drug-related deaths presented during hospitalization		during the year 2015	Yes
Secondary	Risk factors of drug-related deaths	risk factors assessed: age, sex, Charlson score, and hospitalization length	during the year 2015	Yes
Secondary	Incidence of drug-related deaths of all inpatients deaths		during the year 2015.	Yes