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Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department

Prognostic Accuracy of qSOFA Score, SIRS Criteria, and EWSs for In-hospital Mortality Among Adult Patients Presenting With Suspected Infection to the Emergency Department (PASSEM): Protocol for an International Multicentre Prospective External Validation Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05172479
Acronym
PASSEM
Enrollment
3274
Registered
2021-12-29
Start date
2021-12-12
Completion date
2023-09-11
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

Sepsis, Septic shock, qSOFA, SIRS, EWS, NEWS, NEWS2, MEWS, Emergency department

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).

Interventions

DIAGNOSTIC_TESTMeasurement of qSOFA score

At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's qSOFA score.

DIAGNOSTIC_TESTMeasurement of SIRS criteria

At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's SIRS criteria.

DIAGNOSTIC_TESTMeasurement of NEWS

At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS.

DIAGNOSTIC_TESTMeasurement of NEWS2

At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS2.

DIAGNOSTIC_TESTMeasurement of MEWS

At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's MEWS.

Sponsors

Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
CollaboratorUNKNOWN
King Khalid University (KKU)
CollaboratorUNKNOWN
Aseer Central Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult patients (age ≥18 years), 2. Suspected infection (based on the opinion of the emergency physician), 3. Planned for hospitalization, 4. Willing to give oral informed consent (if required by recruiting center's IRB).

Exclusion criteria

1. Presentation to ED is not due to infection (e.g., autoimmune diseases, myocardial infarction, stroke, venous thromboembolism, trauma, intoxication … etc.), 2. Pregnancy, 3. Transferred from another hospitals, 4. Code status is Do-Not-Resuscitate (DNR) 5. Elective admission through ED 6. Initial diagnosis of infection in the ED was not confirmed after finishing of the recruitment and follow-up phase.

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality30 daysMortality rate during hospitalization of patient

Secondary

MeasureTime frameDescription
Intensive care unit admission30 daysNumber of participants admitted to an intensive care unit
Length of stay in the intensive care unit30 daysStay in intensive care unit \>72 hours

Countries

Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, Turkey (Türkiye), United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026