## Protocol Section
### Identification Module
**NCT ID:** NCT05172479

**Acronym:** PASSEM

**Brief Title:** 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

#### Organization Study ID Info
**ID:** ACH-2
#### Organization
**Class:** OTHER_GOV
**Full Name:** Aseer Central Hospital
### Status Module
#### Completion Date
**Date:** 2023-09-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-13

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-11

**Type:** ACTUAL

#### Start Date
**Date:** 2021-12-12

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2021-12-29
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-03
**Study First Submit QC Date:** 2021-12-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

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

**Class:** UNKNOWN

**Name:** King Khalid University (KKU)

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Aseer Central Hospital

#### Responsible Party

**Investigator Affiliation:** Aseer Central Hospital

**Investigator Full Name:** Abdullah M Algarni

**Investigator Title:** Family medicine consultant

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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).

### Conditions Module

**Conditions:**

- Sepsis

- Septic Shock

**Keywords:**

- Sepsis

- Septic shock

- qSOFA

- SIRS

- EWS

- NEWS

- NEWS2

- MEWS

- Emergency department

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 3274

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: Measurement of qSOFA score

**Label:** Positive qSOFA

#### Arm Group 2

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

**Intervention Names:**

- Diagnostic Test: Measurement of qSOFA score

**Label:** Negative qSOFA

#### Arm Group 3

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

**Intervention Names:**

- Diagnostic Test: Measurement of SIRS criteria

**Label:** Positive SIRS

#### Arm Group 4

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

**Intervention Names:**

- Diagnostic Test: Measurement of SIRS criteria

**Label:** Negative SIRS

#### Arm Group 5

**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

**Intervention Names:**

- Diagnostic Test: Measurement of NEWS

**Label:** Positive NEWS

#### Arm Group 6

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

**Intervention Names:**

- Diagnostic Test: Measurement of NEWS

**Label:** Negative NEWS

#### Arm Group 7

**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

**Intervention Names:**

- Diagnostic Test: Measurement of NEWS2

**Label:** Positive NEWS2

#### Arm Group 8

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

**Intervention Names:**

- Diagnostic Test: Measurement of NEWS2

**Label:** Negative NEWS2

#### Arm Group 9

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

**Intervention Names:**

- Diagnostic Test: Measurement of MEWS

**Label:** Positive MEWS

#### Arm Group 10

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

**Intervention Names:**

- Diagnostic Test: Measurement of MEWS

**Label:** Negative MEWS

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Negative qSOFA

- Positive qSOFA

**Description:** 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.

**Name:** Measurement of qSOFA score

**Other Names:**

- quick Sequential Organ Failure Assessment (qSOFA)

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Negative SIRS

- Positive SIRS

**Description:** 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.

**Name:** Measurement of SIRS criteria

**Other Names:**

- Systemic inflammatory response syndrome (SIRS)

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- Negative NEWS

- Positive NEWS

**Description:** 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.

**Name:** Measurement of NEWS

**Other Names:**

- National Early Warning Score (NEWS)

**Type:** DIAGNOSTIC_TEST

#### Intervention 4

**Arm Group Labels:**

- Negative NEWS2

- Positive NEWS2

**Description:** 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.

**Name:** Measurement of NEWS2

**Other Names:**

- National Early Warning Score 2 (NEWS2)

**Type:** DIAGNOSTIC_TEST

#### Intervention 5

**Arm Group Labels:**

- Negative MEWS

- Positive MEWS

**Description:** 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.

**Name:** Measurement of MEWS

**Other Names:**

- Modified Early Warning Score (MEWS)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Mortality rate during hospitalization of patient

**Measure:** In-hospital mortality

**Time Frame:** 30 days

#### Secondary Outcomes

**Description:** Number of participants admitted to an intensive care unit

**Measure:** Intensive care unit admission

**Time Frame:** 30 days

**Description:** Stay in intensive care unit \>72 hours

**Measure:** Length of stay in the intensive care unit

**Time Frame:** 30 days

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ar Rifā'

**Country:** Bahrain

**Facility:** Bahrain Defence Force Hospital

**State:** Southern Governorate

**Zip:** 947

**Location 2:**

**City:** Muharraq

**Country:** Bahrain

**Facility:** King Hamad University Hospital

**Location 3:**

**City:** Kuwait

**Country:** Kuwait

**Facility:** Amiri Hospital

**Location 4:**

**City:** Muscat

**Country:** Oman

**Facility:** Armed Forces Hospital Oman

**Zip:** 111

**Location 5:**

**City:** Doha

**Country:** Qatar

**Facility:** Hamad Medical Corporation

**Location 6:**

**City:** Abha

**Country:** Saudi Arabia

**Facility:** Aseer Central Hospital (ACH)

**State:** Aseer Province

**Zip:** 62523

**Location 7:**

**City:** Khamis Mushait

**Country:** Saudi Arabia

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

**State:** Aseer Province

**Zip:** 62413

**Location 8:**

**City:** Dammam

**Country:** Saudi Arabia

**Facility:** King Fahad Specialist Hospital

**State:** Eastern Province

**Zip:** 32253

**Location 9:**

**City:** Dhahran

**Country:** Saudi Arabia

**Facility:** Johns Hopkins Aramco Healthcare

**State:** Eastern Province

**Zip:** 34465

**Location 10:**

**City:** Jubail

**Country:** Saudi Arabia

**Facility:** Royal Commission Hospital in Jubail

**State:** Eastern Province

**Zip:** 31961

**Location 11:**

**City:** Jeddah

**Country:** Saudi Arabia

**Facility:** King Abdulaziz University Hospital

**State:** Makkah Al Mukarramah Province

**Zip:** 22252

**Location 12:**

**City:** Jeddah

**Country:** Saudi Arabia

**Facility:** King Fahd Armed Forces Hospital

**State:** Makkah Al Mukarramah Province

**Zip:** 23311

**Location 13:**

**City:** Arar

**Country:** Saudi Arabia

**Facility:** North Medical Tower

**State:** Northern Borders Province

**Zip:** 73241

**Location 14:**

**City:** Riyadh

**Country:** Saudi Arabia

**Facility:** King Abdullah bin Abdulaziz University Hospital (KAAUH)

**State:** Riyadh Province

**Zip:** 11564

**Location 15:**

**City:** Riyadh

**Country:** Saudi Arabia

**Facility:** King Fahad Medical City (KFMC)

**State:** Riyadh Province

**Zip:** 12231

**Location 16:**

**City:** Riyadh

**Country:** Saudi Arabia

**Facility:** King Saud Medical City (KSMC)

**State:** Riyadh Province

**Zip:** 12746

**Location 17:**

**City:** Riyadh

**Country:** Saudi Arabia

**Facility:** Sulaiman Al-Habib Hospital

**Location 18:**

**City:** Kocaeli

**Country:** Turkey

**Facility:** Kocaeli University Hospital

**Zip:** 41380

**Location 19:**

**City:** Abu Dhabi

**Country:** United Arab Emirates

**Facility:** Sheikh Shakhbout Medical City

**Location 20:**

**City:** Dubai

**Country:** United Arab Emirates

**Facility:** Rashid Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Aseer Central Hospital (ACH)

**Name:** Abdullah M Algarni, MBBS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### 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.

**PMID:** 38232095

#### See Also Links

**Label:** Protocol preprint

**URL:** https://www.medrxiv.org/content/10.1101/2022.03.19.22272537v1

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000018805

- Term: Sepsis

- ID: D000007239

- Term: Infections

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000012769

- Term: Shock

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15580

- Name: Shock, Septic

- Relevance: HIGH

- As Found: Septic Shock

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M20864

- Name: Sepsis

- Relevance: LOW

- As Found: Unknown

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012772

- Term: Shock, Septic

- ID: D000004630

- Term: Emergencies

### Misc Info Module

- Version Holder: 2024-05-24
