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

A

Aseer Central Hospital

Status

Completed

Conditions

Septic Shock
Sepsis

Treatments

Diagnostic Test: Measurement of NEWS2
Diagnostic Test: Measurement of SIRS criteria
Diagnostic Test: Measurement of MEWS
Diagnostic Test: Measurement of qSOFA score
Diagnostic Test: Measurement of NEWS

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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).

Enrollment

3,274 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

3,274 participants in 10 patient groups

Positive qSOFA
Description:
Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of qSOFA score
Negative qSOFA
Description:
Adult patients with suspected infection and a qSOFA score \< 2 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of qSOFA score
Positive SIRS
Description:
Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of SIRS criteria
Negative SIRS
Description:
Adult patients with suspected infection and a SIRS criteria \< 2 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of SIRS criteria
Positive NEWS
Description:
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
Treatment:
Diagnostic Test: Measurement of NEWS
Negative NEWS
Description:
Adult patients with suspected infection and a NEWS \< 5 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of NEWS
Positive NEWS2
Description:
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
Treatment:
Diagnostic Test: Measurement of NEWS2
Negative NEWS2
Description:
Adult patients with suspected infection and a NEWS2 \< 5 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of NEWS2
Positive MEWS
Description:
Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of MEWS
Negative MEWS
Description:
Adult patients with suspected infection and a MEWS \< 5 at the triage in the ED who are planned for hospitalization
Treatment:
Diagnostic Test: Measurement of MEWS

Trial contacts and locations

20

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Central trial contact

Ali A Al Bshabshe, MBBS; Abdullah M Algarni, MBBS

Data sourced from clinicaltrials.gov

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