Multicenter Study of Generation Comorbidity Score | NCT01346111

Studies
Multicenter Study of Generation Comorbidity Score

NCT01346111

Sponsor

Hospital Italiano de Buenos Aires

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

2,640Actual

Phase

Not provided

Conditions

Death

Interventions

Not provided

Countries

Argentina

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

Aug 2019

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

Apr 2009

Primary Completion Date

Jul 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

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

Aug 9, 2019

Last Update Posted Date

Aug 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos AiresPrincipal Investigator

Lead Sponsor

Hospital Italiano de Buenos AiresOTHER

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

2,640Actual

Label	Type	Description	Intervention Names
generation cohort		Included 5 hospitals from Buenos Aires, Argentina

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
generate a co-morbidity score	Generate a co-morbidity score that measures the weight for individuals morbidities with respect to death.	12 months follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult 17 older
admitted to hospital within 72 hours of admission
non programed admission

Exclusion Criteria:

negative to participate
72 hs mortality expected
obstetrics admissions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adults, who were admitted to hospital for a non programme admission, medical or surgical admission

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diego H Giunta, MD	Hospital Italiano de Buenos Aires	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Interzonal General de Agudos Piñeyro		Junín	Buenos Aires	1181	Argentina
Hospital Complejo Médico de la Policía Federal Argentina Churruca-Visca

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided