Adverse Drug Reactions With Fatal Outcome

July 15, 2016 updated by: Eva Montané, Germans Trias i Pujol Hospital
The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All inpatients dead in the Germans Trias i Pujol University Hospital during the year 2015.

Patients with a death diagnosis in a predefined list of medical conditions, potentially caused by drugs, were the selected cases for further review.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Drug-related deaths
fatal adverse drug reactions
Drug: adverse drug reaction
drug-related death
Other Names:
  • side effect
non drug-related deaths
deaths for other causes different as drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of drug-related deaths of all hospital admissions
Time Frame: during the year 2015
during the year 2015

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of drug-related deaths with the suspected drug started the previous week
Time Frame: during the year 2015
during the year 2015
Number of drug-related deaths with drug interactions between suspected drugs
Time Frame: during the year 2015
during the year 2015
Number of preventable drug-related deaths assessed by Schumock criteria
Time Frame: during the year 2015
during the year 2015
Number of drug-related deaths with polypharmacy
Time Frame: during the year 2015
Polypharmacy: when patient received >10 drugs
during the year 2015
Number of drug-related deaths with autopsy
Time Frame: during the year 2015
during the year 2015
Number of drug-related deaths in which the suspected drug had a contributive role
Time Frame: during the year 2015
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
during the year 2015
Number of drug-related deaths presented during hospitalization
Time Frame: during the year 2015
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
during the year 2015
Incidence of drug-related deaths of all inpatients deaths
Time Frame: during the year 2015.
during the year 2015.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: Eva Montané, PhD, Department of Clinical Pharmacology. Hospital Universitari Germans Trias i Pujol. Badalona, Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAM-MORT 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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