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| Name | Class |
|---|---|
| Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM) | UNKNOWN |
| King Khalid University (KKU) | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive qSOFA | Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization |
| |
| Negative qSOFA | Adult patients with suspected infection and a qSOFA score < 2 at the triage in the ED who are planned for hospitalization |
| |
| Positive SIRS | Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization |
| |
| Negative SIRS | Adult patients with suspected infection and a SIRS criteria < 2 at the triage in the ED who are planned for hospitalization |
| |
| 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 |
| |
| Negative NEWS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Mortality rate during hospitalization of patient | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit admission | Number of participants admitted to an intensive care unit | 30 days |
| Length of stay in the intensive care unit | Stay in intensive care unit >72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Abdullah M Algarni, MBBS | Aseer Central Hospital (ACH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahrain Defence Force Hospital | Riffa | Southern Governorate | 947 | Bahrain | ||
| King Hamad University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38232095 | Background | 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. |
| Label | URL |
|---|---|
| Protocol preprint | View source |
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Adult patients with suspected infection and a NEWS < 5 at the triage in the ED who are planned for hospitalization |
|
| 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 |
|
| Negative NEWS2 | Adult patients with suspected infection and a NEWS2 < 5 at the triage in the ED who are planned for hospitalization |
|
| Positive MEWS | Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization |
|
| Negative MEWS | Adult patients with suspected infection and a MEWS < 5 at the triage in the ED who are planned for hospitalization |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 30 days |
| Al Muharraq |
| Bahrain |
| Amiri Hospital | Kuwait City | Kuwait |
| Armed Forces Hospital Oman | Muscat | 111 | Oman |
| Hamad Medical Corporation | Doha | Qatar |
| Aseer Central Hospital (ACH) | Abhā | Aseer Province | 62523 | Saudi Arabia |
| Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM) | Khamis Mushait | Aseer Province | 62413 | Saudi Arabia |
| King Fahad Specialist Hospital | Dammam | Eastern Province | 32253 | Saudi Arabia |
| Johns Hopkins Aramco Healthcare | Dhahran | Eastern Province | 34465 | Saudi Arabia |
| Royal Commission Hospital in Jubail | Jubail | Eastern Province | 31961 | Saudi Arabia |
| King Abdulaziz University Hospital | Jeddah | Makkah Al Mukarramah Province | 22252 | Saudi Arabia |
| King Fahd Armed Forces Hospital | Jeddah | Makkah Al Mukarramah Province | 23311 | Saudi Arabia |
| North Medical Tower | Arar | Northern Borders Province | 73241 | Saudi Arabia |
| King Abdullah bin Abdulaziz University Hospital (KAAUH) | Riyadh | Riyadh Region | 11564 | Saudi Arabia |
| King Fahad Medical City (KFMC) | Riyadh | Riyadh Region | 12231 | Saudi Arabia |
| King Saud Medical City (KSMC) | Riyadh | Riyadh Region | 12746 | Saudi Arabia |
| Sulaiman Al-Habib Hospital | Riyadh | Saudi Arabia |
| Kocaeli University Hospital | Kocaeli | 41380 | Turkey (Türkiye) |
| Sheikh Shakhbout Medical City | Abu Dhabi | United Arab Emirates |
| Rashid Hospital | Dubai | United Arab Emirates |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D020969 | Disease Attributes |
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