Clinical trial NCT05172479: Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Septic shock
qSOFA
SIRS
EWS
NEWS
NEWS2
MEWS
Emergency department
Lead sponsor: Aseer Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
name: King Khalid University (KKU)
First posted: 2021-12-29
Enrollment: 3274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: In-hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: Intensive care unit admission
timeFrame: 30 days
measure: Length of stay in the intensive care unit
timeFrame: 30 days
Other outcomes:
Locations:
city: Ar Rifā'
country: Bahrain
facility: Bahrain Defence Force Hospital
state: Southern Governorate
city: Muharraq
country: Bahrain
facility: King Hamad University Hospital
city: Kuwait
country: Kuwait
facility: Amiri Hospital
city: Muscat
country: Oman
facility: Armed Forces Hospital Oman
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Abha
country: Saudi Arabia
facility: Aseer Central Hospital (ACH)
state: Aseer Province
city: Khamis Mushait
country: Saudi Arabia
facility: Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
state: Aseer Province
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital
state: Eastern Province
city: Dhahran
country: Saudi Arabia
facility: Johns Hopkins Aramco Healthcare
state: Eastern Province
city: Jubail
country: Saudi Arabia
facility: Royal Commission Hospital in Jubail
state: Eastern Province
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
state: Makkah Al Mukarramah Province
city: Jeddah
country: Saudi Arabia
facility: King Fahd Armed Forces Hospital
state: Makkah Al Mukarramah Province
city: Arar
country: Saudi Arabia
facility: North Medical Tower
state: Northern Borders Province
city: Riyadh
country: Saudi Arabia
facility: King Abdullah bin Abdulaziz University Hospital (KAAUH)
state: Riyadh Province
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City (KFMC)
state: Riyadh Province
city: Riyadh
country: Saudi Arabia
facility: King Saud Medical City (KSMC)
state: Riyadh Province
city: Riyadh
country: Saudi Arabia
facility: Sulaiman Al-Habib Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
city: Dubai
country: United Arab Emirates
facility: Rashid Hospital
Study officials:
affiliation: Aseer Central Hospital (ACH)
name: Abdullah M Algarni, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.