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

August 2, 2017 updated by: Vicente Lopes da Silva Junior, Unimed Volta Redonda

Sepse: Critical Analysis of New Sepse Studies and Definitions and Retrospective Evaluation of Sepse Protocol Implementation at Hospital Unimed Volta Redonda

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

506

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rio de Janeiro
      • Volta Redonda, Rio de Janeiro, Brazil, 27258-000
        • Recruiting
        • Vicente Lopes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2015
2015 - Individuals with a diagnosis of sepsis from June 2014 to May 2015
Adherence to the sepsis protocol
2016
2016 -Individuals with a diagnosis of sepsis from June 2015 to May 2016
Adherence to the sepsis protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Leila Auler, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2017

Primary Completion (Anticipated)

August 5, 2017

Study Completion (Anticipated)

August 8, 2017

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HUVR17.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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