Adverse Drug ReactionNCT02838212
Adverse Drug Reactions With Fatal Outcome
An observational study of Adverse Drug Reaction, run by Germans Trias i Pujol Hospital.
Trial summary
The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Reaction
- What is being tested?
- adverse drug reaction
- How many people
- 1,135 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- inpatients deaths and drug-related deaths.
Who cannot join
- death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.
About this study
The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015
Read the detailed description
The investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015
- Conditions
- Adverse Drug Reaction
- Being tested
- adverse drug reaction
- Keywords
- adverse drug reaction, hospital mortality, incidence
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adverse drug reactionDrug
Also called side effect
drug-related death
| Study group | Role | What they receive |
|---|---|---|
| Drug-related deaths | fatal adverse drug reactions Receives: Drug: adverse drug reaction | |
| non drug-related deaths | deaths for other causes different as drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of drug-related deaths of all hospital admissions
Measured: during the year 2015
Secondary outcomes (10)
Number of drug-related deaths with the suspected drug started the previous week
Measured: during the year 2015
Number of drug-related deaths with drug interactions between suspected drugs
Measured: during the year 2015
Number of preventable drug-related deaths assessed by Schumock criteria
Measured: during the year 2015
Number of drug-related deaths with polypharmacy
Polypharmacy: when patient received >10 drugs
Measured: during the year 2015
Number of drug-related deaths with autopsy
Measured: during the year 2015
Number of drug-related deaths in which the suspected drug had a contributive role
Measured: during the year 2015
Number of drug-related deaths with "certain" or "probable" categories assessed by World Health Organization (WHO) criteria and Naranjo algorithm
Measured: during the year 2015
Number of drug-related deaths presented during hospitalization
Measured: during the year 2015
Risk factors of drug-related deaths
risk factors assessed: age, sex, Charlson score, and hospitalization length
Measured: during the year 2015
Incidence of drug-related deaths of all inpatients deaths
Measured: during the year 2015.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Montané, Germans Trias i Pujol Hospital
- Investigators
- Eva Montané, PhD, Principal investigator, Department of Clinical Pharmacology. Hospital Universitari Germans Trias i Pujol. Badalona, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838212
- Sponsor's protocol ID
- RAM-MORT 2015
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Drug Reactions With Fatal Outcome
- ClinicalTrials.gov ID
- NCT02838212
- Acronym / sponsor ID
- RAM-MORT 2015
- Conditions
- Adverse Drug Reaction
- Keywords
- adverse drug reaction, hospital mortality, incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,135 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-related deaths | – | Drug: adverse drug reactionfatal adverse drug reactions |
| non drug-related deaths | – | –deaths for other causes different as drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- inpatients deaths and drug-related deaths.
Key exclusion criteria (1 listed)
- death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adverse drug reactionAlso: side effectdrug-related death | Drug | Drug-related deaths |
Primary outcome
Incidence of drug-related deaths of all hospital admissions
Time frame: during the year 2015
10 secondary outcomes
Number of drug-related deaths with the suspected drug started the previous week
Time frame: during the year 2015
Number of drug-related deaths with drug interactions between suspected drugs
Time frame: during the year 2015
Number of preventable drug-related deaths assessed by Schumock criteria
Time frame: during the year 2015
Number of drug-related deaths with polypharmacy
Time frame: during the year 2015
Number of drug-related deaths with autopsy
Time frame: during the year 2015
Number of drug-related deaths in which the suspected drug had a contributive role
Time frame: 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
Number of drug-related deaths presented during hospitalization
Time frame: during the year 2015
Risk factors of drug-related deaths
Time frame: during the year 2015
Incidence of drug-related deaths of all inpatients deaths
Time frame: during the year 2015.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Adverse Drug Reaction
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
Active, not recruiting
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Montané, PhD principal investigator
Department of Clinical Pharmacology. Hospital Universitari Germans Trias i Pujol. Badalona, Barcelona, Spain
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reaction, run by Germans Trias i Pujol Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of drug-related deaths of all hospital admissions (time frame: during the year 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.