Clinical trial NCT03158493: Assessment of qSOFA in the Latin America Sepsis Institute Database
Official title: Assessment of qSOFA in the Latin America Sepsis Institute Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Latin America Sepsis Institute
First posted: 2017-05-18
Enrollment: 8435
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis and sepsis shock, defined by the presence of any organ dyfunctionn

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Hospital mortality
timeFrame: From date of inclusion through study completion, assessed up to 100 months
Secondary outcomes:
measure: admission to ICU in the first 24 hours of the diagnosis of sepsis
timeFrame: From date of inclusion until 24 hours after the diagnosis of sepsis, assessed up to 24 hours after the diagnosis of sepsis
measure: length of ICU stay of more than 48 hours
timeFrame: From date of inclusion until 2 days after ICU admission
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Flavia R Machado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.