SepsisHUVRNCT03217981
Sepse: Critical Analysis of New Sepse Definitions and Retrospective Evaluation of Sepse Protocol at a Tertiary Hospital in Brazil
An observational study of Sepsis, run by Unimed Volta Redonda at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Sepsis protocol
- How many people
- 506 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2017to 8 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age hospitalized with suspected or confirmed diagnosis of sepsis at HUVR.
Who may be able to join
- All individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period.
- -
Who cannot join
- Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.
- Individuals under the age of 18
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Vicente Lopes
Volta Redonda, Rio de Janeiro, 27258-000
Vicente Lopes, +5521981227376, vlsjunior@uol.com.br
About this study
Official title: 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.
- Conditions
- Sepsis
- Being tested
- Sepsis protocol
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepsis protocolOther
Adherence to the sepsis protocol
| Study group | Role | What they receive |
|---|---|---|
| 2015 | 2015 - Individuals with a diagnosis of sepsis from June 2014 to May 2015 Receives: Other: Sepsis protocol | |
| 2016 | 2016 -Individuals with a diagnosis of sepsis from June 2015 to May 2016 Receives: Other: Sepsis protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the sepsis protocol
Implementation of the measures recommended in the sepsis protocol
Measured: From 2014 to 2016
Secondary outcomes (1)
Sepsis mortality rate
Assessment of the evolution of the sepsis mortality rate
Measured: From 2014 to 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start2 Aug 2017
- Primary completion5 Aug 2017 (estimated)
- Study completion8 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unimed Volta Redonda
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Lopes da Silva Junior, Unimed Volta Redonda
- Investigators
- Leila Auler, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217981
- Sponsor's protocol ID
- HUVR17.1
- Acronym
- HUVR
- Status last verified
- Aug 2017
- First submitted
- 12 Jul 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepse: Critical Analysis of New Sepse Studies and Definitions and Retrospective Evaluation of Sepse Protocol Implementation at Hospital Unimed Volta Redonda
- ClinicalTrials.gov ID
- NCT03217981
- Acronym / sponsor ID
- HUVR / HUVR17.1
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Unimed Volta RedondaUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 5 Aug 2017 (estimated)
- Study completion
- 8 Aug 2017 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2015 | – | Other: Sepsis protocol2015 - Individuals with a diagnosis of sepsis from June 2014 to May 2015 |
| 2016 | – | Other: Sepsis protocol2016 -Individuals with a diagnosis of sepsis from June 2015 to May 2016 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age hospitalized with suspected or confirmed diagnosis of sepsis at HUVR.
Key inclusion criteria (2 listed)
- All individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period.
- -
Key exclusion criteria (3 listed)
- Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.
- Individuals under the age of 18
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sepsis protocolAdherence to the sepsis protocol | Other | 2015, 2016 |
Primary outcome
Adherence to the sepsis protocol
Time frame: From 2014 to 2016
Implementation of the measures recommended in the sepsis protocol
1 secondary outcome
Sepsis mortality rate
Time frame: From 2014 to 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Auler study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Unimed Volta Redonda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicente L da Silva Jr (+5521981227376, vicente.junior@unimedvr.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the sepsis protocol (time frame: From 2014 to 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.