Sepse: Critical Analysis of New Sepse Definitions and Ret... | NCT03217981

Studies
Sepse: Critical Analysis of New Sepse Definitions and Retrospective Evaluation of Sepse Protocol at a Tertiary Hospital in Brazil

NCT03217981

Sponsor

Unimed Volta Redonda

Status

Unknown status

Last Update Posted

Aug 4, 2017Actual

Enrollment

506Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Sepsis protocol

Countries

Brazil

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 2017

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

Aug 2, 2017Actual

Primary Completion Date

Aug 5, 2017Estimated

Completion Date

Aug 8, 2017Estimated

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 12, 2017

First Posted Date

Jul 14, 2017Actual

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 2, 2017

Last Update Posted Date

Aug 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vicente Lopes da Silva Junior, Principal Investigator, Unimed Volta RedondaPrincipal Investigator

Lead Sponsor

Unimed Volta RedondaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English language. Selection of the main articles of the last five years to study and contextualize the reality presented since the implantation of the HUVR sepsis protocol. Statistical analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014 until June 2016.

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

506Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2015		2015 - Individuals with a diagnosis of sepsis from June 2014 to May 2015	Other: Sepsis protocol
2016		2016 -Individuals with a diagnosis of sepsis from June 2015 to May 2016	Other: Sepsis protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sepsis protocol	Other	Adherence to the sepsis protocol	2015 2016

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to the sepsis protocol	Implementation of the measures recommended in the sepsis protocol	From 2014 to 2016

Secondary Outcomes

Measure	Description	Time Frame
Sepsis mortality rate	Assessment of the evolution of the sepsis mortality rate	From 2014 to 2016

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period.

Exclusion Criteria:

Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.

Individuals under the age of 18

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

Patients over 18 years of age hospitalized with suspected or confirmed diagnosis of sepsis at HUVR.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vicente L da Silva Jr	Contact	+5521981227376		vicente.junior@unimedvr.com.br

Overall Officials

Name	Affiliation	Role
Leila Auler	Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vicente Lopes	Recruiting	Volta Redonda	Rio de Janeiro	27258-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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