Sepsis Institutional Registry in Hospital Italiano de Bue... | NCT01403935

Studies
Sepsis Institutional Registry in Hospital Italiano de Buenos Aires

NCT01403935

Sponsor

Hospital Italiano de Buenos Aires

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

7,472Actual

Phase

Not provided

Conditions

Death
Severe Sepsis

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

Dec 2007

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 26, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 27, 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 this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

Detailed Description

The main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the Hospital Italiano de Buenos Aires.

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

7,472Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical features, mortality		Clinical characteristics are evaluated during the acute event and in-hospital mortality and annual monitoring

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 17 years
Two or more sirs criteria
Active infection

Exclusion Criteria:

Refusal to register or to the informed consent process
Ambulatory patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with sepsis

Sampling Method

Non-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 Italiano de Buenos Aires, Gascon 450		Buenos Aires			Argentina

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death
D018805	Sepsis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided