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Completed

NCT Number: NCT05172479

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bahrain Defence Force Hospital, Riffa, Southern Governorate, Bahrain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Measurement of qSOFA score

Diagnostic Test

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.

Other names: quick Sequential Organ Failure Assessment (qSOFA)

Measurement of SIRS criteria

Diagnostic Test

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.

Other names: Systemic inflammatory response syndrome (SIRS)

Measurement of NEWS

Diagnostic Test

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.

Other names: National Early Warning Score (NEWS)

Measurement of NEWS2

Diagnostic Test

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.

Other names: National Early Warning Score 2 (NEWS2)

Measurement of MEWS

Diagnostic Test

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.

Other names: Modified Early Warning Score (MEWS)

Primary outcomes

  1. In-hospital mortality

    Time frame: 30 days

    Mortality rate during hospitalization of patient

Secondary outcomes

  1. Intensive care unit admission

    Time frame: 30 days

    Number of participants admitted to an intensive care unit

  2. Length of stay in the intensive care unit

    Time frame: 30 days

    Stay in intensive care unit >72 hours

Sponsors and collaborators

Lead sponsor

Aseer Central Hospital

Other Gov

Collaborators

  • Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
  • King Khalid University (KKU)

Registry information

Official study title

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

Acronym: PASSEM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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