Derivation and Validation of a Prognostic Model for Septi... | NCT03601767

Studies
Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission

NCT03601767

Sponsor

Azienda Ospedaliera San Paolo

Status

Unknown status

Last Update Posted

Jul 26, 2018Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

Italy

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 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2017Actual

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Aug 1, 2019Estimated

First Submitted Date

May 30, 2018

First Submission Date that Met QC Criteria

Jul 25, 2018

First Posted Date

Jul 26, 2018Actual

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 25, 2018

Last Update Posted Date

Jul 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Livio Colombo, Consultant in Acute Medicine, Azienda Ospedaliera San PaoloPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera San PaoloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 aim of the present study is to develop a prognostic tool to assess the risk of dead and major complications in patient admitted to hospital for infection. A detailed database of clinical, biochemical and microbiological data is recorded and each item is analyzed and compared with clinical outcomes to develop a prognostic score.

Detailed Description

Not provided

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

600Estimated

Measure	Description	Time Frame
mortality		at 28 days

Measure	Description	Time Frame
major complications		at 28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

al least 18 years old
admission to hospital for any infection for more than 72 hours

Exclusion Criteria:

pregnancy

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

subjects presenting to the accident and emergency department and admitted to hospital for any infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Livio Colombo, MD	Contact	+390281844250		livio.colombo@asst-santipaolocarlo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Paolo Polo Univesitario - ASST Santi Paolo e Carlo	Recruiting	Milan		20142	Italy

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided