DeathNCT01346111
Multicenter Study of Generation Comorbidity Score
An observational study of Death, run by Hospital Italiano de Buenos Aires at 5 sites in Argentina.
Trial summary
The purpose of the study is to generate and valid a co-morbidity score with updated definitions and suitable for use in Argentina in both public and private settings. These tools would allow us to compare different populations in Argentina adjusting for comorbidities. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Death
- How many people
- 2,640 participants
- Where
- 5 sitesArgentina
- Study dates
- Apr 2009to Dec 2014
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults, who were admitted to hospital for a non programme admission, medical or surgical admission
Who may be able to join
- Adult 17 older
- admitted to hospital within 72 hours of admission
- non programed admission
Who cannot join
- negative to participate
- 72 hs mortality expected
- obstetrics admissions
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Argentina5 sites
Hospital Complejo Médico de la Policía Federal Argentina Churruca-Visca
Buenos Aires, 1181
Hospital General de Agudos Vélez Sarfield
Buenos Aires, 1181
Hospital Italiano de Buenos Aires
Buenos Aires, 1181
Hospital Interzonal General de Agudos Piñeyro
Junín, Buenos Aires, 1181
Hospital Lagomaggiore
Mendoza
About this study
Official title: Multicenter Study for the Generation of a Score of Comorbidities
The purpose of the study is to generate and valid a co-morbidity score with updated definitions and suitable for use in Argentina in both public and private settings. These tools would allow us to compare different populations in Argentina adjusting for comorbidities. Also, this would potentially help attending physicians and health administrators.
Read the detailed description
The investigators will generate a co-morbidity score, perform the score validation and generate an online calculator for the score (open access).
Finally, a score validation for extreme values of score will be performed to ensure representativeness of these patients.
- Conditions
- Death
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| generation cohort | Included 5 hospitals from Buenos Aires, Argentina |
What is being measured
The primary outcome is the main question the study is designed to answer.
generate a co-morbidity score
Generate a co-morbidity score that measures the weight for individuals morbidities with respect to death.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2009
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies 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
- Prospective
- Enrolment
- 2,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Diego H Giunta, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346111
- Sponsor's protocol ID
- 1385
- Status last verified
- Aug 2019
- First submitted
- 29 Apr 2011
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study for the Generation of a Score of Comorbidities
- ClinicalTrials.gov ID
- NCT01346111
- Acronym / sponsor ID
- 1385
- Conditions
- Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,640 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 May 2011 (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 the study is to generate and valid a co-morbidity score with updated definitions and suitable for use in Argentina in both public and private settings. These tools would allow us to compare different populations in Argentina adjusting for comorbidities. Also, this would potentially help attending physicians and health administrators.
Detailed description
The investigators will generate a co-morbidity score, perform the score validation and generate an online calculator for the score (open access).
Finally, a score validation for extreme values of score will be performed to ensure representativeness of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| generation cohort | – | –Included 5 hospitals from Buenos Aires, Argentina |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, who were admitted to hospital for a non programme admission, medical or surgical admission
Key inclusion criteria (3 listed)
- Adult 17 older
- admitted to hospital within 72 hours of admission
- non programed admission
Key exclusion criteria (3 listed)
- negative to participate
- 72 hs mortality expected
- obstetrics admissions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
generate a co-morbidity score
Time frame: 12 months follow up
Generate a co-morbidity score that measures the weight for individuals morbidities with respect to death.
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 13 Aug 2019.
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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.
Diego H Giunta, MD principal investigator
Hospital Italiano de Buenos Aires
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, run by Hospital Italiano de Buenos Aires at 5 sites in Argentina.
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 3 inclusion and 3 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
generate a co-morbidity score (time frame: 12 months follow up). 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 13 Aug 2019.