Adverse Drug Reactions With Fatal Outcome

NCT02838212 | Completed

• 1 other identifier: RAM-MORT 2015
• Study Type: observational
• Target: 1,135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Adverse Drug Reaction

Keywords

adverse drug reaction; hospital mortality; incidence

Outcome Measures

Primary Outcomes (1)

• Incidence of drug-related deaths of all hospital admissions

  during the year 2015

Secondary Outcomes (10)

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

  during the year 2015

• Number of drug-related deaths with drug interactions between suspected drugs

  during the year 2015

• Number of preventable drug-related deaths assessed by Schumock criteria

  during the year 2015

• Number of drug-related deaths with polypharmacy

  during the year 2015

• Number of drug-related deaths with autopsy

  during the year 2015

Study Arms (2)

Drug-related deaths

fatal adverse drug reactions

Drug: adverse drug reaction

non drug-related deaths

deaths for other causes different as drugs

Interventions

adverse drug reaction DRUG

drug-related death

Also known as: side effect

Drug-related deaths

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• inpatients deaths and drug-related deaths.

You may not qualify if:

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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Adverse Drug Reaction Reporting Systems; Psychology

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Product Surveillance, Postmarketing; Evaluation Studies as Topic; Investigative Techniques; Drug Information Services; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Eva Montané, PhD

  Department of Clinical Pharmacology. Hospital Universitari Germans Trias i Pujol. Badalona, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacologist

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share