Assessment of qSOFA in the Latin America Sepsis Institute Database

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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,
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

Exclusion criteria

End of life care
Previous sepsis episode in the same hospital admission

Treatment and study plan

Primary outcomes

Hospital mortality

Time frame: From date of inclusion through study completion, assessed up to 100 months

mortality at hospital

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

number of patients who were admitted in the intensive care unit
length of ICU stay of more than 48 hours

Time frame: From date of inclusion until 2 days after ICU admission

duration of ICU stay was greater than 2 days

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

Latin America Sepsis Institute

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 18, 2017
Registry last updated: May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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