SepsisNCT03158493
Assessment of qSOFA in the Latin America Sepsis Institute Database
An observational study of Sepsis, run by Federal University of São Paulo.
Trial summary
Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a fairly robust analysis of large, essentially American, databases. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis
- How many people
- 8,435 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Apr 2017
- How long will I take part?
- 4 Weeks
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sepsis and sepsis shock, defined by the presence of any organ dyfunctionn
Who may be able to join
- Suspected source of infection
- Presence of any of the following organ dysfunction
- Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg.
- Creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours OR
- Bilirubin> 2mg/dl,
- Platelet count<100,000,
Show all 9Show fewer
- Lactate> 2 mmol/dl (or above the reference value),
- Coagulopathy (RNI> 1.5 or APTT>60 sec),
- PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90
Who cannot join
- End of life care
- Previous sepsis episode in the same hospital admission
About this study
Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a fairly robust analysis of large, essentially American, databases. In addition to the new definition, a new screening score was suggested, named quickSOFA (qSOFA). This score is positive if two of three variables are present: respiratory rate higher than 22 ipm, reduced level of consciousness and systolic blood pressure lower than 100 mmHg. Although the receiver operator characteristics (ROC) curves suggest an adequate predictive validity for the new score, a lot of controversy around its sensitivity as a screening tool mainly in settings with high mortality rates. Current national Brazilian data show that sepsis mortality in our country, especially in public hospitals from the Unified Health System (SUS), is very high and well above world mortality. The impact of using the qSOFA in these settings is not known. In this context, the present study aims to evaluate the potential impact of using qSOFA as a screening tool in Brazilian private and public institutions. The hypothesis is that the use of qSOFA as a screening tool will have a low sensitivity. As a consequence, patients with the diagnosis of sepsis, with organ dysfunction, will not be detected by this tool. The hypothesis was also that those patients with a qSOFA negative will have a high mortality rate, mainly in Brazilian public hospitals.
Read the detailed description
All hospitals in the Latin America Sepsis Institute network were invited to participate. This is a national based quality improvement initiative aiming to improve compliance with the sepsis bundles and mortality. The hospitals were instructed to include all patients that presented with the diagnosis of sepsis or septic shock in the emergency department (ED), wards or ICU. The diagnosis of sepsis was based on the previous criteria used by the network, which means presence of suspected infection and an infection-associated organ dysfunction. Organ dysfunction was defined by the presence of any of the following: systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg; creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours, bilirubin> 2mg/dl, platelet count<100,000, lactate> 2 mmol/dl (or above the reference value), coagulopathy (RNI> 1.5 or APTT>60 sec), PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90. Suspected of infection was based on the clinical suspicious by the attending physician. All patients under end-of-life care and those previously included in the database in the same hospital admission were excluded.
The case managers were instructed to collect the 3 components of the qSOFA criteria, namely reduced level of consciousness, respiratory rate higher than 22 bpm and systolic blood pressure lower than 100 mmHg). In patients included from the ED, these components were checked at the time of triage. In patients in the wards or in the ICU, the 3 components were considered if presented any time in the 24 hours prior to the diagnosis of sepsis.
Outcomes Primary outcome was hospital mortality. Secondary endpoints included admission to ICU and length of ICU stay of more than 48 hours. A secondary composite outcome was hospital mortality plus ICU length of stay higher than two days (for those admitted to the ICU).
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
mortality at hospital
Measured: From date of inclusion through study completion, assessed up to 100 months
Secondary outcomes (2)
admission to ICU in the first 24 hours of the diagnosis of sepsis
number of patients who were admitted in the intensive care unit
Measured: From date of inclusion until 24 hours after the diagnosis of sepsis, assessed up to 24 hours after the diagnosis of sepsis
length of ICU stay of more than 48 hours
duration of ICU stay was greater than 2 days
Measured: From date of inclusion until 2 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startMay 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 8,435 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Latin America Sepsis Institute
- Responsible party
- Principal investigator, Flavia Ribeiro Machado, Federal University of São Paulo
- Investigators
- Flavia R Machado, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158493
- Sponsor's protocol ID
- 00691812.3.0000.5505
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Machado FR, Cavalcanti AB, Monteiro MB, Sousa JL, Bossa A, Bafi AT, Dal-Pizzol F, Freitas FGR, Lisboa T, Westphal GA, Japiassu AM, Azevedo LCP; Instituto Latino-Americano de Sepsis network investigators. Predictive Accuracy of the Quick Sepsis-related Organ Failure Assessment Score in Brazil. A Prospective Multicenter Study. Am J Respir Crit Care Med. 2020 Apr 1;201(7):789-798. doi: 10.1164/rccm.201905-0917OC.
PubMed 31910037
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of qSOFA in the Latin America Sepsis Institute Database
- ClinicalTrials.gov ID
- NCT03158493
- Acronym / sponsor ID
- 00691812.3.0000.5505
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,435 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Latin America Sepsis Institute
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 May 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.
Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a fairly robust analysis of large, essentially American, databases. In addition to the new definition, a new screening score was suggested, named quickSOFA (qSOFA). This score is positive if two of three variables are present: respiratory rate higher than 22 ipm, reduced level of consciousness and systolic blood pressure lower than 100 mmHg. Although the receiver operator characteristics (ROC) curves suggest an adequate predictive validity for the new score, a lot of controversy around its sensitivity as a screening tool mainly in settings with high mortality rates. Current national Brazilian data show that sepsis mortality in our country, especially in public hospitals from the Unified Health System (SUS), is very high and well above world mortality. The impact of using the qSOFA in these settings is not known. In this context, the present study aims to evaluate the potential impact of using qSOFA as a screening tool in Brazilian private and public institutions. The hypothesis is that the use of qSOFA as a screening tool will have a low sensitivity. As a consequence, patients with the diagnosis of sepsis, with organ dysfunction, will not be detected by this tool. The hypothesis was also that those patients with a qSOFA negative will have a high mortality rate, mainly in Brazilian public hospitals.
Detailed description
All hospitals in the Latin America Sepsis Institute network were invited to participate. This is a national based quality improvement initiative aiming to improve compliance with the sepsis bundles and mortality. The hospitals were instructed to include all patients that presented with the diagnosis of sepsis or septic shock in the emergency department (ED), wards or ICU. The diagnosis of sepsis was based on the previous criteria used by the network, which means presence of suspected infection and an infection-associated organ dysfunction. Organ dysfunction was defined by the presence of any of the following: systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg; creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours, bilirubin> 2mg/dl, platelet count<100,000, lactate> 2 mmol/dl (or above the reference value), coagulopathy (RNI> 1.5 or APTT>60 sec), PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90. Suspected of infection was based on the clinical suspicious by the attending physician. All patients under end-of-life care and those previously included in the database in the same hospital admission were excluded.
The case managers were instructed to collect the 3 components of the qSOFA criteria, namely reduced level of consciousness, respiratory rate higher than 22 bpm and systolic blood pressure lower than 100 mmHg). In patients included from the ED, these components were checked at the time of triage. In patients in the wards or in the ICU, the 3 components were considered if presented any time in the 24 hours prior to the diagnosis of sepsis.
Outcomes Primary outcome was hospital mortality. Secondary endpoints included admission to ICU and length of ICU stay of more than 48 hours. A secondary composite outcome was hospital mortality plus ICU length of stay higher than two days (for those admitted to the ICU).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sepsis and sepsis shock, defined by the presence of any organ dyfunctionn
Key inclusion criteria (9 listed)
- Suspected source of infection
- Presence of any of the following organ dysfunction
Key exclusion criteria (2 listed)
- End of life care
- Previous sepsis episode in the same hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital mortality
Time frame: From date of inclusion through study completion, assessed up to 100 months
mortality at hospital
2 secondary outcomes
admission to ICU in the first 24 hours of the diagnosis of sepsis
Time frame: From date of inclusion until 24 hours after the diagnosis of sepsis, assessed up to 24 hours after the diagnosis of sepsis
length of ICU stay of more than 48 hours
Time frame: From date of inclusion until 2 days after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 31910037Machado FR, Cavalcanti AB, Monteiro MB, Sousa JL, Bossa A, Bafi AT, Dal-Pizzol F, Freitas FGR, Lisboa T, Westphal GA, Japiassu AM, Azevedo LCP; Instituto Latino-Americano de Sepsis network investigators. Predictive Accuracy of the Quick Sepsis-related Organ Failure Assessment Score in Brazil. A Prospective Multicenter Study. Am J Respir Crit Care Med. 2020 Apr 1;201(7):789-798. doi: 10.1164/rccm.201905-0917OC.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Flavia R Machado, MD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Federal University of São Paulo.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: From date of inclusion through study completion, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158493, which also lists 1 linked publication.
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 23 May 2017.