Adverse Drug Reactions With Fatal Outcome

Sponsor

Germans Trias i Pujol Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02838212

Collaborator

(none)

1,135

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adverse Drug Reaction	Drug: adverse drug reaction

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 Design

Study Type:

Observational

Actual Enrollment :

1135 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Adverse Drug Reactions With Fatal Outcome

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Incidence of drug-related deaths of all hospital admissions [during the year 2015]

Secondary Outcome Measures

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]
Polypharmacy: when patient received >10 drugs
Number of drug-related deaths with autopsy [during the year 2015]
Number of drug-related deaths in which the suspected drug had a contributive role [during the year 2015]
Number of drug-related deaths with "certain" or "probable" categories assessed by World Health Organization (WHO) criteria and Naranjo algorithm [during the year 2015]
Number of drug-related deaths presented during hospitalization [during the year 2015]
Risk factors of drug-related deaths [during the year 2015]
risk factors assessed: age, sex, Charlson score, and hospitalization length
Incidence of drug-related deaths of all inpatients deaths [during the year 2015.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eva Montané, Clinical Pharmacologist, Germans Trias i Pujol Hospital

ClinicalTrials.gov Identifier:

NCT02838212

Other Study ID Numbers:

RAM-MORT 2015

First Posted:

Jul 20, 2016

Last Update Posted:

Jul 20, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Eva Montané, Clinical Pharmacologist, Germans Trias i Pujol Hospital

adverse drug reaction

hospital mortality

incidence

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2016