SepsisqSOFANCT05584098
MEWS, qSOFA and Physiological Parameters Combination in the Emergency Room
A study testing qSOFA, MEWS and physiological parameters combination in people with Sepsis, run by St. Martin De Porress Hospital at 2 sites in Taiwan.
Trial summary
In the development of sepsis treatment of recent years, the demand for medical manpower has increased significantly when patients with sepsis appear because of the expansion of medical care demand and shortened response time related to sepsis Due to the shortage of manpower, a more simple and easy-to-operate… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- What is being tested?
- qSOFA, MEWS and physiological parameters combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 2 sitesTaiwan
- Study dates
- 20 Mar 2022to 30 Sep 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- This is a single-center retrospective study of a group of patients admitted to the emergency department.
Who cannot join
- Patients with incomplete treatment clinical data, lack of information in medical records, trauma patients
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
St. Martin De Porres Hospital
Chiayi City, 600046
St. Martin De Porres Hospital
Chiayi City, 60069
About this study
Official title: Modified Early Warning Score (MEWS), Quick Sequential Organ Failure Assessment (qSOFA) and Physiological Parameters Combination to Predict the Occurrence of Sepsis in the Emergency Room
In the development of sepsis treatment of recent years, the demand for medical manpower has increased significantly when patients with sepsis appear because of the expansion of medical care demand and shortened response time related to sepsis Due to the shortage of manpower, a more simple and easy-to-operate inspection method is adopted and artificial intelligence technology is used to assist in the evaluation.
The applicability of physiological indicators MEWS, qSOFA and physiological parameters combination as sepsis screening tools in emergency department (ED) and predicting sepsis outcome in the emergency department. When patients with sepsis appear, artificial intelligence technology is used to remind the physicians to respond and administer drugs as soon as possible.
This is a single-center retrospective study of a group of patients admitted to the emergency department. The medical records were reviewed, mainly based on the hospital site records and the existing vital signs of the patients. Attended a hospital emergency room between January 2020 and December 2022. Physiological numerical indicators MEWS and qSOFA were all scored to understand the distribution of sepsis.
Read the detailed description
- A single-center retrospective study of a cohort of patients admitted to the emergency department
- To see a doctor in the emergency department of the hospital between January 2020 and December 2022, review their medical records, and focus on the hospital's on-site records and the existing patient's vital signs.
- The physiological indicators MEWS and qSOFA were scored to understand the distribution of sepsis.
- Remind the doctor when a suspected sepsis patient appears under level 5 triage and use artificial intelligence technology to assist
- This study will explore the specific improvement practices and effects of improving the response of patients with sepsis when they see a doctor
- To analyze and evaluate the economics and benefits of this operation mode, improve the accuracy of emergency inspection of sepsis patients and improve the rationality of hospital manpower deployment
- Scheduled progress of the plan: Patients who visited the emergency department of the hospital between January 2020 and December 2022 were included in this study under investigation. This is a retrospective study, and patients are required to undergo necessary examinations according to their own conditions, without any interference from the study
- Conditions
- Sepsis
- Being tested
- qSOFA, MEWS and physiological parameters combination
- Keywords
- Sepsis, Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA), emergency Medicine, physiological parameters combination
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qSOFA, MEWS and physiological parameters combinationOther
qSOFA ,MEWS and physiological parameters combination used in emergency medicine department could be helpful in the identification of the occurrence of sepsis
| Study group | Role | What they receive |
|---|---|---|
| qSOFA, MEWS and physiological parameters combination | Other | Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA) and physiological parameters combination are used in prediction of occurrence of sepsis Receives: Other: qSOFA, MEWS and physiological parameters combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
qSOFA used in emergency medicine department
The qSOFA score is a simple score consisting of three items: respiratory rate (RR) ≥ 22 breaths per minute, altered mentation (Glasgow Coma Scale [GCS] < 15), and systolic blood pressure (SBP) < 100 mmHg and lowest score is 1 and highest is 3. The more score will show more severe disease.
MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended
Measured: From date of randomization until the date of first documented progression assessed up to 36 months
Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention
MEWS score = Systolic blood pressure + Heart rate + Urine output + Respiratory rate + Temperature + AVPU. The lowest score is 0 and highest score is 14. The more score will show more severe disease.
MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended
Measured: From date of randomization until the date of first documented progression assessed up to 36 months
physiological parameters combination
Shock Index (SI) = Heart Rate / Systolic Blood Pressure Age-Adjusted Shock Index (Age SI) = Age x Shock Index Respiratory-Adjusted Shock Index (RASI) = HR/SBP × (RR/10)
Measured: From date of randomization until the date of first documented progression assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Mar 2022
- Primary completion10 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time.
- Masking
- None (open label)
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Martin De Porress Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-hsi Chen, St. Martin De Porress Hospital
- Investigators
- Chia-Hsi Chen, MD, Principal investigator, Emergency Medicine Department of St. Martin De Porres Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584098
- Sponsor's protocol ID
- 21B-004
- Acronym
- qSOFA
- Status last verified
- Aug 2025
- First submitted
- 7 Oct 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) is not available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Early Warning Score (MEWS), Quick Sequential Organ Failure Assessment (qSOFA) and Physiological Parameters Combination to Predict the Occurrence of Sepsis in the Emergency Room
- ClinicalTrials.gov ID
- NCT05584098
- Acronym / sponsor ID
- qSOFA / 21B-004
- Conditions
- Sepsis
- Keywords
- Sepsis, Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA), emergency Medicine, physiological parameters combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- St. Martin De Porress HospitalUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Oct 2022 (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.
In the development of sepsis treatment of recent years, the demand for medical manpower has increased significantly when patients with sepsis appear because of the expansion of medical care demand and shortened response time related to sepsis Due to the shortage of manpower, a more simple and easy-to-operate inspection method is adopted and artificial intelligence technology is used to assist in the evaluation.
The applicability of physiological indicators MEWS, qSOFA and physiological parameters combination as sepsis screening tools in emergency department (ED) and predicting sepsis outcome in the emergency department. When patients with sepsis appear, artificial intelligence technology is used to remind the physicians to respond and administer drugs as soon as possible.
This is a single-center retrospective study of a group of patients admitted to the emergency department. The medical records were reviewed, mainly based on the hospital site records and the existing vital signs of the patients. Attended a hospital emergency room between January 2020 and December 2022. Physiological numerical indicators MEWS and qSOFA were all scored to understand the distribution of sepsis.
Detailed description
- A single-center retrospective study of a cohort of patients admitted to the emergency department
- To see a doctor in the emergency department of the hospital between January 2020 and December 2022, review their medical records, and focus on the hospital's on-site records and the existing patient's vital signs.
- The physiological indicators MEWS and qSOFA were scored to understand the distribution of sepsis.
- Remind the doctor when a suspected sepsis patient appears under level 5 triage and use artificial intelligence technology to assist
- This study will explore the specific improvement practices and effects of improving the response of patients with sepsis when they see a doctor
- To analyze and evaluate the economics and benefits of this operation mode, improve the accuracy of emergency inspection of sepsis patients and improve the rationality of hospital manpower deployment
- Scheduled progress of the plan: Patients who visited the emergency department of the hospital between January 2020 and December 2022 were included in this study under investigation. This is a retrospective study, and patients are required to undergo necessary examinations according to their own conditions, without any interference from the study
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time.
| Arm | Type | Receives |
|---|---|---|
| qSOFA, MEWS and physiological parameters combination | Other | Other: qSOFA, MEWS and physiological parameters combinationModified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA) and physiological parameters combination are used in prediction of occurrence of sepsis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- This is a single-center retrospective study of a group of patients admitted to the emergency department.
Key exclusion criteria (1 listed)
- Patients with incomplete treatment clinical data, lack of information in medical records, trauma patients
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 |
|---|---|---|
| qSOFA, MEWS and physiological parameters combinationqSOFA ,MEWS and physiological parameters combination used in emergency medicine department could be helpful in the identification of the occurrence of sepsis | Other | qSOFA, MEWS and physiological parameters combination |
Primary outcome
qSOFA used in emergency medicine department
Time frame: From date of randomization until the date of first documented progression assessed up to 36 months
The qSOFA score is a simple score consisting of three items: respiratory rate (RR) ≥ 22 breaths per minute, altered mentation (Glasgow Coma Scale [GCS] < 15), and systolic blood pressure (SBP) < 100 mmHg and lowest score is 1 and highest is 3. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended
Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention
Time frame: From date of randomization until the date of first documented progression assessed up to 36 months
MEWS score = Systolic blood pressure + Heart rate + Urine output + Respiratory rate + Temperature + AVPU. The lowest score is 0 and highest score is 14. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended
physiological parameters combination
Time frame: From date of randomization until the date of first documented progression assessed up to 36 months
Shock Index (SI) = Heart Rate / Systolic Blood Pressure Age-Adjusted Shock Index (Age SI) = Age x Shock Index Respiratory-Adjusted Shock Index (RASI) = HR/SBP × (RR/10)
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 8 Sep 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) is not available to other researchers
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Chia-Hsi Chen, MD principal investigator
Emergency Medicine Department of St. Martin De Porres Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qSOFA, MEWS and physiological parameters combination in people with Sepsis, run by St. Martin De Porress Hospital at 2 sites in Taiwan.
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 1 inclusion and 1 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
qSOFA used in emergency medicine department (time frame: From date of randomization until the date of first documented progression assessed up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.