NCT03217981

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

August 2, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

3 days

First QC Date

July 12, 2017

Last Update Submit

August 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to the sepsis protocol

    Implementation of the measures recommended in the sepsis protocol

    From 2014 to 2016

Secondary Outcomes (1)

  • Sepsis mortality rate

    From 2014 to 2016

Study Arms (2)

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

Adherence to the sepsis protocol

20152016

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.
  • Individuals under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vicente Lopes

Volta Redonda, Rio de Janeiro, 27258-000, Brazil

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leila Auler

    Director

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 14, 2017

Study Start

August 2, 2017

Primary Completion

August 5, 2017

Study Completion

August 8, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations