SepsisPASSEMNCT05172479
Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department
An observational study of Sepsis and Septic Shock, run by Aseer Central Hospital at 20 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Measurement of qSOFA score, Measurement of SIRS criteria and Measurement of NEWS
- How many people
- 3,274 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 12 Dec 2021to 11 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Saudi Arabia12 sites
Aseer Central Hospital (ACH)
Abhā, Aseer Province, 62523
North Medical Tower
Arar, Northern Borders Province, 73241
King Fahad Specialist Hospital
Dammam, Eastern Province, 32253
Johns Hopkins Aramco Healthcare
Dhahran, Eastern Province, 34465
King Abdulaziz University Hospital
Jeddah, Makkah Al Mukarramah Province, 22252
King Fahd Armed Forces Hospital
Jeddah, Makkah Al Mukarramah Province, 23311
Royal Commission Hospital in Jubail
Jubail, Eastern Province, 31961
Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
Khamis Mushait, Aseer Province, 62413
King Abdullah bin Abdulaziz University Hospital (KAAUH)
Riyadh, Riyadh Region, 11564
King Fahad Medical City (KFMC)
Riyadh, Riyadh Region, 12231
King Saud Medical City (KSMC)
Riyadh, Riyadh Region, 12746
Sulaiman Al-Habib Hospital
Riyadh
Bahrain2 sites
King Hamad University Hospital
Al Muharraq
Bahrain Defence Force Hospital
Riffa, Southern Governorate, 947
United Arab Emirates2 sites
Sheikh Shakhbout Medical City
Abu Dhabi
Rashid Hospital
Dubai
About this study
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
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).
Read the 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
- Sepsis, Septic Shock
- Being tested
- Measurement of qSOFA score, Measurement of SIRS criteria, Measurement of NEWS, Measurement of NEWS2, Measurement of MEWS
- Keywords
- Sepsis, Septic shock, qSOFA, SIRS, EWS, NEWS, NEWS2, MEWS, Emergency department
- Medical subject headings
- Sepsis, Shock, Septic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of qSOFA scoreDiagnostic test
Also called quick Sequential Organ Failure Assessment (qSOFA)
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.
Measurement of SIRS criteriaDiagnostic test
Also called Systemic inflammatory response syndrome (SIRS)
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 NEWSDiagnostic test
Also called National Early Warning Score (NEWS)
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 NEWS2Diagnostic test
Also called National Early Warning Score 2 (NEWS2)
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 MEWSDiagnostic test
Also called Modified Early Warning Score (MEWS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive qSOFA | Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Measurement of MEWS |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Mortality rate during hospitalization of patient
Measured: 30 days
Secondary outcomes (2)
Intensive care unit admission
Number of participants admitted to an intensive care unit
Measured: 30 days
Length of stay in the intensive care unit
Stay in intensive care unit >72 hours
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start12 Dec 2021
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aseer Central Hospital
- Sponsor type
- Other government
- Collaborators
- Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM), King Khalid University (KKU)
- Responsible party
- Principal investigator, Abdullah M Algarni, Aseer Central Hospital
- Investigators
- Abdullah M Algarni, MBBS, Principal investigator, Aseer Central Hospital (ACH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172479
- Sponsor's protocol ID
- ACH-2
- Acronym
- PASSEM
- Status last verified
- Sep 2023
- First submitted
- 3 Dec 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38232095
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05172479
- Acronym / sponsor ID
- PASSEM / ACH-2
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, qSOFA, SIRS, EWS, NEWS, NEWS2, MEWS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,274 participants (actual)
- Lead sponsor
- Aseer Central HospitalOther government
- Collaborators
- Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM), King Khalid University (KKU)
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Positive qSOFA | – | Diagnostic Test: Measurement of qSOFA scoreAdult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization |
| Negative qSOFA | – | Diagnostic Test: Measurement of qSOFA scoreAdult patients with suspected infection and a qSOFA score < 2 at the triage in the ED who are planned for hospitalization |
| Positive SIRS | – | Diagnostic Test: Measurement of SIRS criteriaAdult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization |
| Negative SIRS | – | Diagnostic Test: Measurement of SIRS criteriaAdult patients with suspected infection and a SIRS criteria < 2 at the triage in the ED who are planned for hospitalization |
| Positive NEWS | – | Diagnostic Test: Measurement of NEWSAdult 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 | – | Diagnostic Test: Measurement of NEWSAdult patients with suspected infection and a NEWS < 5 at the triage in the ED who are planned for hospitalization |
| Positive NEWS2 | – | Diagnostic Test: Measurement of NEWS2Adult 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 | – | Diagnostic Test: Measurement of NEWS2Adult patients with suspected infection and a NEWS2 < 5 at the triage in the ED who are planned for hospitalization |
| Positive MEWS | – | Diagnostic Test: Measurement of MEWSAdult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization |
| Negative MEWS | – | Diagnostic Test: Measurement of MEWSAdult patients with suspected infection and a MEWS < 5 at the triage in the ED who are planned for hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of qSOFA scoreAlso: quick Sequential Organ Failure Assessment (qSOFA)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. | Diagnostic test | Negative qSOFA, Positive qSOFA |
| Measurement of SIRS criteriaAlso: Systemic inflammatory response syndrome (SIRS)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. | Diagnostic test | Negative SIRS, Positive SIRS |
| Measurement of NEWSAlso: National Early Warning Score (NEWS)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. | Diagnostic test | Negative NEWS, Positive NEWS |
| Measurement of NEWS2Also: National Early Warning Score 2 (NEWS2)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. | Diagnostic test | Negative NEWS2, Positive NEWS2 |
| Measurement of MEWSAlso: Modified Early Warning Score (MEWS)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. | Diagnostic test | Negative MEWS, Positive MEWS |
Primary outcome
In-hospital mortality
Time frame: 30 days
Mortality rate during hospitalization of patient
2 secondary outcomes
Intensive care unit admission
Time frame: 30 days
Length of stay in the intensive care unit
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 38232095Algarni 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah M Algarni, MBBS principal investigator
Aseer Central Hospital (ACH)
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Aseer Central Hospital at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Saudi Arabia, Bahrain, United Arab Emirates, Kuwait, Oman and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.