- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217981
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
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
-
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brazil, 27258-000
- Recruiting
- Vicente Lopes
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Contact:
- Vicente Lopes
- Phone Number: +5521981227376
- Email: vlsjunior@uol.com.br
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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.
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Exclusion Criteria:
Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.
Individuals under the age of 18
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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
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Adherence to the sepsis protocol
|
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2016
2016 -Individuals with a diagnosis of sepsis from June 2015 to May 2016
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Adherence to the sepsis protocol
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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
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Implementation of the measures recommended in the sepsis protocol
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From 2014 to 2016
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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
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From 2014 to 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Clinical Trials on Sepsis
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University of California, San FranciscoNational Cancer Institute (NCI)RecruitingSepsis | Sepsis, Severe | Sepsis and Septic Shock | Sepsis at Intensive Care Unit | Sepsis, Septic Shock | Sepsis, Severe Sepsis and Septic Shock | Sepsis With Multiple Organ Dysfunction (MOD) | Sepsis With Acute Organ DysfunctionUnited States
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Assiut UniversityNot yet recruitingSepsis Induced Myocardial Dysfunction | Sepsis Induced CardiomyopathyEgypt
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
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Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
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The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
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Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
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Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityEnrolling by invitationSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
Clinical Trials on Sepsis protocol
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Intermountain Health Care, Inc.National Institute of General Medical Sciences (NIGMS)Completed
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Orange Park Medical Center410 MedicalCompletedSepsis | Shock, Septic | Fluid Therapy | Emergency Medical Services | Quality ImprovementUnited States
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Vanderbilt UniversityNational Institutes of Health (NIH); Fogarty International Center of the National...Terminated
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Vanderbilt UniversityNational Institutes of Health (NIH); Fogarty International Center of the National...CompletedSepsis | Tuberculosis | Severe SepsisZambia
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Kuopio University HospitalCompleted
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DascenaUniversity of California, San FranciscoCompleted
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DascenaCabell Huntington HospitalCompletedSepsis | Septic Shock | Severe SepsisUnited States
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Xinhua Hospital, Shanghai Jiao Tong University...Completed
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National Taiwan University Hospital Hsin-Chu BranchUnknownSepsis | Peripheral Artery Disease | Diagnosis | Peripheral Artery OcclusionTaiwan