Adverse Drug Reactions With Fatal Outcome | NCT02838212

Studies
Adverse Drug Reactions With Fatal Outcome

NCT02838212

Sponsor

Germans Trias i Pujol Hospital

Status

Completed

Last Update Posted

Jul 20, 2016Estimated

Enrollment

1,135Actual

Phase

Not provided

Conditions

Adverse Drug Reaction

Interventions

adverse drug reaction

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 13, 2016

First Submission Date that Met QC Criteria

Jul 15, 2016

First Posted Date

Jul 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2016

Last Update Posted Date

Jul 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Montané, Clinical Pharmacologist, Germans Trias i Pujol HospitalPrincipal Investigator

Lead Sponsor

Germans Trias i Pujol HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug-related deaths		fatal adverse drug reactions	Drug: adverse drug reaction
non drug-related deaths		deaths for other causes different as drugs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
adverse drug reaction	Drug	drug-related death	Drug-related deaths	side effect

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016907	Adverse Drug Reaction Reporting Systems
D011584	Psychology

Ancestor Terms

ID	Term
D011358	Product Surveillance, Postmarketing
D005069	Evaluation Studies as Topic
D008919	Investigative Techniques
D004346	Drug Information Services

Browse Leaves

Not provided

Browse Branches

Not provided