Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department
- Conditions
- SepsisSeptic Shock
- Interventions
- Diagnostic Test: Measurement of MEWSDiagnostic Test: Measurement of SIRS criteriaDiagnostic Test: Measurement of NEWSDiagnostic Test: Measurement of qSOFA scoreDiagnostic Test: Measurement of NEWS2
- Registration Number
- NCT05172479
- Lead Sponsor
- Aseer Central Hospital
- Brief Summary
Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).
- Detailed Description
Over the past decade, medical advances in sepsis continued to focus on sepsis as a prevalent condition that accounts for 10% of admissions to intensive care units (ICUs) and is associated with a 10-20% in-hospital mortality rate. Standardised protocols and physician awareness have significantly improved survival, but mortality rates remain between 20% and 36%, with \~270,000 deaths annually in the United States. However, of patients with sepsis, 80% are treated in an emergency department (ED), and the remainder develops sepsis during hospitalisation with other conditions. In 2016, the Society of Critical Care Medicine/European Society of Intensive Care Medicine (SCCM/ESICM) task force redefined sepsis based on organ dysfunction and mortality prediction. Sepsis now is defined as life-threatening organ dysfunction caused by dysregulated host response to infection. This definition emphasises the complexity of the disease that cannot be explained by infection or body response to it. Acute change in Sequential Organ Failure Assessment (SOFA) score ≥2 indicates sepsis-related organ dysfunction, a predictor of excess in-hospital mortality. Systemic Inflammatory Response Syndrome (SIRS) and "severe sepsis" terms were omitted from the most recent definition. SIRS has been criticised for its poor specificity, while "severe sepsis" may underestimate sepsis's seriousness. A subset of patients may develop septic shock with underlying profound organ dysfunction and excess mortality. Clinically, septic shock is defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and serum lactate level ≥ 2 mmol/L (18 mg/dL) despite adequate volume resuscitation. Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3274
- Adult patients (age ≥18 years),
- Suspected infection (based on the opinion of the emergency physician),
- Planned for hospitalization,
- Willing to give oral informed consent (if required by recruiting center's IRB).
- Presentation to ED is not due to infection (e.g., autoimmune diseases, myocardial infarction, stroke, venous thromboembolism, trauma, intoxication ... etc.),
- Pregnancy,
- Transferred from another hospitals,
- Code status is "Do-Not-Resuscitate" (DNR)
- Elective admission through ED
- Initial diagnosis of infection in the ED was not confirmed after finishing of the recruitment and follow-up phase.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Negative MEWS Measurement of MEWS Adult patients with suspected infection and a MEWS \< 5 at the triage in the ED who are planned for hospitalization Positive SIRS Measurement of SIRS criteria Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization Positive NEWS Measurement of NEWS Adult patients with suspected infection and a NEWS ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization Positive qSOFA Measurement of qSOFA score Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization Negative qSOFA Measurement of qSOFA score Adult patients with suspected infection and a qSOFA score \< 2 at the triage in the ED who are planned for hospitalization Negative SIRS Measurement of SIRS criteria Adult patients with suspected infection and a SIRS criteria \< 2 at the triage in the ED who are planned for hospitalization Negative NEWS Measurement of NEWS Adult patients with suspected infection and a NEWS \< 5 at the triage in the ED who are planned for hospitalization Positive NEWS2 Measurement of NEWS2 Adult patients with suspected infection and a NEWS2 ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization Negative NEWS2 Measurement of NEWS2 Adult patients with suspected infection and a NEWS2 \< 5 at the triage in the ED who are planned for hospitalization Positive MEWS Measurement of MEWS Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization
- Primary Outcome Measures
Name Time Method In-hospital mortality 30 days Mortality rate during hospitalization of patient
- Secondary Outcome Measures
Name Time Method Length of stay in the intensive care unit 30 days Stay in intensive care unit \>72 hours
Intensive care unit admission 30 days Number of participants admitted to an intensive care unit
Trial Locations
- Locations (20)
Bahrain Defence Force Hospital
🇧🇭Ar Rifā', Southern Governorate, Bahrain
King Hamad University Hospital
🇧🇭Muharraq, Bahrain
Amiri Hospital
🇰🇼Kuwait, Kuwait
Armed Forces Hospital Oman
🇴🇲Muscat, Oman
Hamad Medical Corporation
🇶🇦Doha, Qatar
Aseer Central Hospital (ACH)
🇸🇦Abha, Aseer Province, Saudi Arabia
Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
🇸🇦Khamis Mushait, Aseer Province, Saudi Arabia
King Fahad Specialist Hospital
🇸🇦Dammam, Eastern Province, Saudi Arabia
Johns Hopkins Aramco Healthcare
🇸🇦Dhahran, Eastern Province, Saudi Arabia
Royal Commission Hospital in Jubail
🇸🇦Jubail, Eastern Province, Saudi Arabia
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