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

NCT05172479 | Completed DMC

• 1 other identifier: ACH-2
• Study Type: observational
• Target: 3,274
• Locations: 7 countries
• Sites: 20

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).

Conditions

Sepsis; Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Mortality rate during hospitalization of patient

  30 days

Secondary Outcomes (2)

• Intensive care unit admission

  30 days

• Length of stay in the intensive care unit

  30 days

Study Arms (10)

Positive qSOFA

Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of qSOFA score

Negative qSOFA

Adult patients with suspected infection and a qSOFA score \< 2 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of qSOFA score

Positive SIRS

Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of SIRS criteria

Negative SIRS

Adult patients with suspected infection and a SIRS criteria \< 2 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of SIRS criteria

Positive 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

Diagnostic Test: Measurement of NEWS

Negative NEWS

Adult patients with suspected infection and a NEWS \< 5 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of NEWS

Positive 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

Diagnostic Test: Measurement of NEWS2

Negative NEWS2

Adult patients with suspected infection and a NEWS2 \< 5 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of NEWS2

Positive MEWS

Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of MEWS

Negative MEWS

Adult patients with suspected infection and a MEWS \< 5 at the triage in the ED who are planned for hospitalization

Diagnostic Test: Measurement of MEWS

Interventions

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.

Also known as: quick Sequential Organ Failure Assessment (qSOFA)

Negative qSOFA; Positive 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.

Also known as: Systemic inflammatory response syndrome (SIRS)

Negative SIRS; Positive 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.

Also known as: National Early Warning Score (NEWS)

Negative NEWS; Positive 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.

Also known as: National Early Warning Score 2 (NEWS2)

Negative NEWS2; Positive 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.

Also known as: Modified Early Warning Score (MEWS)

Negative MEWS; Positive MEWS

Eligibility Criteria

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

Study Population

All consecutive adult patients (age ≥18 years) presenting to the ED with suspected infection who planned to be hospitalized and willing to give informed consent (if required by recruiting center IRB) are eligible. A presumptive diagnosis of infection will be judged based on the opinion of the emergency physician upon the initial patient presentation to the ED. We will exclude patients with evidence of other causes of presentation to the ED other than infection (e.g., autoimmune diseases, myocardial infarction, trauma, …etc.), pregnant ladies, those who transferred from other hospitals, those not planned for hospitalization, or those who admitted electively to the hospital through ED. We will also exclude patients whose initial diagnosis of infection in the ED was not confirmed after the recruitment and follow-up.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aseer Central Hospital: lead
• Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM): collaborator
• King Khalid University (KKU): collaborator

Study Sites (20)

Bahrain Defence Force Hospital

Riffa, Southern Governorate, 947, Bahrain

Location

King Hamad University Hospital

Al Muharraq, Bahrain

Location

Amiri Hospital

Kuwait City, Kuwait

Location

Armed Forces Hospital Oman

Muscat, 111, Oman

Location

Hamad Medical Corporation

Doha, Qatar

Location

Aseer Central Hospital (ACH)

Abhā, Aseer Province, 62523, Saudi Arabia

Location

Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)

Khamis Mushait, Aseer Province, 62413, Saudi Arabia

Location

King Fahad Specialist Hospital

Dammam, Eastern Province, 32253, Saudi Arabia

Location

Johns Hopkins Aramco Healthcare

Dhahran, Eastern Province, 34465, Saudi Arabia

Location

Royal Commission Hospital in Jubail

Jubail, Eastern Province, 31961, Saudi Arabia

Location

King Abdulaziz University Hospital

Jeddah, Makkah Al Mukarramah Province, 22252, Saudi Arabia

Location

King Fahd Armed Forces Hospital

Jeddah, Makkah Al Mukarramah Province, 23311, Saudi Arabia

Location

North Medical Tower

Arar, Northern Borders Province, 73241, Saudi Arabia

Location

King Abdullah bin Abdulaziz University Hospital (KAAUH)

Riyadh, Riyadh Region, 11564, Saudi Arabia

Location

King Fahad Medical City (KFMC)

Riyadh, Riyadh Region, 12231, Saudi Arabia

Location

King Saud Medical City (KSMC)

Riyadh, Riyadh Region, 12746, Saudi Arabia

Location

Sulaiman Al-Habib Hospital

Riyadh, Saudi Arabia

Location

Kocaeli University Hospital

Kocaeli, 41380, Turkey (Türkiye)

Location

Sheikh Shakhbout Medical City

Abu Dhabi, United Arab Emirates

Location

Rashid Hospital

Dubai, United Arab Emirates

Location

Related Publications (1)

• Algarni AM, Alfaifi MS, Al Bshabshe AA, Omair OM, Alsultan MA, Alzahrani HM, Alali HE, Alsabaani AA, Alqarni AM, Alghanem SA, Al Mufareh BS, Almemari AM, Sindi AA, Ozturan IU, Alhadhira AA, Shujaa AS, Alotaibi AH, Awladthani MM, Alsaad AA, Almarshed AA, AlQahtani AM, Harris TR, Alyahya BA, Assiri SA, Abuzeyad FH, Kazim SN, Al-Fares AA, Almazroua FY, Marzook NT, Basri AA, Elsafti AM, Alalshaikh AS, Ozturan CA, Alawad YI, AlOmari A, Alkhateeb MA, Farooq MM, AlMutairi LA, Alasfour MM, Al Haber MI, Umar UA, Bokhary NH, Alqahtani SF, Almutairi A, Alyahya HF, Alzahrani WS, Alsalmi F, Omair AM, Alasmari FM, Alfifi SY, Al-Nujimi MS, Foroutan F. 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) Multicenter prospective external validation cohort study protocol. PLoS One. 2024 Jan 17;19(1):e0281208. doi: 10.1371/journal.pone.0281208. eCollection 2024.

  PMID: 38232095 BACKGROUND

Related Links

• Protocol preprint

MeSH Terms

Conditions

Sepsis; Shock, Septic; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdullah M Algarni, MBBS

  Aseer Central Hospital (ACH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family medicine consultant

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 29, 2021
• Study Start: December 12, 2021
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

AE (2); KU (1); QA (1); OM (1); BA (2); TU (1); SA (12)