Assessment of qSOFA in the Latin America Sepsis Institute Database

NCT03158493 | Completed

• 1 other identifier: 00691812.3.0000.5505
• Study Type: observational
• Target: 8,435
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  mortality at hospital

  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

  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

  From date of inclusion until 2 days after ICU admission

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sepsis and sepsis shock, defined by the presence of any organ dyfunctionn

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Latin America Sepsis Institute: collaborator

Related Publications (1)

• 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.

  PMID: 31910037 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Flavia R Machado, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 18, 2017
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05