Sepsis in ED PatientsNCT07271329
REDS SCORE VERSUS qSOFA SCORE to Predict Mortality in Patients With Suspected Sepsis
An observational study of Sepsis in ED Patients, run by Assiut University at 1 site in Egypt.
Trial summary
Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis in ED Patients
- What is being tested?
- Sphygmomanometer
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2025to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients.
Who may be able to join
- Adults ≥ 18 y presented to the ED with suspected or confirmed infection, both sex qSOFA criterion met on arrival ≥ 2
Who cannot join
- Patient less than 18 years Incomplete vital sign records upon ED arrival Pregnant patients Those with DNR state Immune compromised patient as leukemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bassant said Mousa Associate Prof of Emergency department Faculty of medicine, Study Principal Investigator contact
About this study
Official title: Risk-stratification of Emergency Department Suspected Sepsis (REDS) Score Versus Quick Sequential Organ Failure Assessment (qSOFA) Score to Predict Mortality in Patients With Suspected Sepsis
Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients.
Read the detailed description
Sepsis is a life threatening condition and a major cause of morbidity and mortality in emergency department worldwide.Patients at high-risk of death may be identified by using an evidence based risk-stratification score. The ED is a busy and hard environment and any score that is used should be easy to calculate using readily available variables. The objective criteria defining sepsis, a minimum two-point increase as in qSoFA score .
The REDS (Risk-stratification of Emergency Department suspected Sepsis) score is a tool used to assess the risk of mortality in patients with suspected sepsis in the emergency department. It combines several factors including age, altered mental state, respiratory rate, systolic blood pressure, serum albumin, INR, lactate levels, and refractory hypotension. A score of 3 or more is considered high-risk. Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients.
The REDS score includes the following variables, each assigned a point value:
Age: ≥ 65 years old (1 point) Altered Mental State: (1 point) Respiratory Rate: ≥ 22 breaths/min (1 point) Systolic Blood Pressure: ≤ 100 mm Hg (1 point) Serum Albumin: ≤ 27 g/L (1 point) INR: ≥ 1.3 (1 point) Lactate: 2.1-3.9 mmol/L (1 point), ≥ 4 mmol/L (3 points) Refractory Hypotension: (2 points for lactate ≤ 2 mmol/L, 3 points for lactate >2 mmol/L)
Interpreting the REDS score:
0-2: Low risk of death 3 or more: High risk of death The REDS score is a useful tool for emergency departments to quickly identify patients who may be at higher risk of mortality from sepsis and need more aggressive or immediate treatment.The quick SOFA (qSOFA) score is a bedside tool used to quickly assess the risk of death or prolonged intensive care unit stay in patients with suspected infection. It uses three criteria: respiratory rate, altered mental status, and systolic blood pressure. A score of 2 or more indicates a higher risk.
qSOFA Criteria:
- Respiratory Rate: 22 breaths per minute or higher.
- Altered Mental Status: A Glasgow Coma Scale score less than 15.
- Systolic Blood Pressure: 100 mmHg or lower.
Scoring:
Each criterion met scores 1 point. A score of 2 or more indicates a higher risk of poor outcome. qSOFA helps identify patients with suspected infection who are likely to have sepsis. It is a rapid assessment tool that can be used in urgent and resource-limited settings
- Conditions
- Sepsis in ED Patients
- Being tested
- Sphygmomanometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SphygmomanometerDevice
Mercury sphygmomanometer for measuring blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Patients will be randomly assigned to two groups: 1) Group A 2)Group B | Patients will be randomly assigned to two groups:
1. Group A: Initial vital signs upon arrival at ED triage to evaluate the REDS score [ Time Frame: Timepoint 0 (ED triage) Age: ≥ 65 years old (1 point) Altered Mental State: (1 point) [from 1-15] Respiratory Rate: ≥22 breaths/min (1point ) [yes or not] Systolic Blood Pressure: ≤100 mm Hg (1 point) [yes or not] Serum Albumin: ≤27 g/L (1 point) [yes or not] INR: ≥1.3 (1 point)[yes or not] Lactate: 2.1-3.9 mmol/L (1 point), ≥4 mmol/L (3 points) Refractory Hypotension: (2 points for lactate ≤2 mmol/L, 3 points for lactate >2 mmol/L) will be assessed to evaluate the REDS score.
2. Group B: Initial vital signs upon arrival at ED triage to evaluate the qSOFA score [ Time Frame: Timepoint 0 (ED triage) ] .
* Respiratory rate per minute
* Mental status
* Systolic blood pressure. Receives: Device: Sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
primary outcome will be mortality during the 30 day follow-up
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startDec 2025 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis in ED PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MN MohamedHussin, Assiut University
- Investigators
- Mohamed Anwar, Consultant of Anathesia ICU, Principal investigator, Assiut UniversityHaitham Mohammed Ahmed, Lecturer of Anesthesia,ICU, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271329
- Sponsor's protocol ID
- Reds score versus qSOFA score
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-stratification of Emergency Department Suspected Sepsis (REDS) Score Versus Quick Sequential Organ Failure Assessment (qSOFA) Score to Predict Mortality in Patients With Suspected Sepsis
- ClinicalTrials.gov ID
- NCT07271329
- Acronym / sponsor ID
- Reds score versus qSOFA score
- Conditions
- Sepsis in ED Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Dec 2025 (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.
Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients.
Detailed description
Sepsis is a life threatening condition and a major cause of morbidity and mortality in emergency department worldwide.Patients at high-risk of death may be identified by using an evidence based risk-stratification score. The ED is a busy and hard environment and any score that is used should be easy to calculate using readily available variables. The objective criteria defining sepsis, a minimum two-point increase as in qSoFA score .
The REDS (Risk-stratification of Emergency Department suspected Sepsis) score is a tool used to assess the risk of mortality in patients with suspected sepsis in the emergency department. It combines several factors including age, altered mental state, respiratory rate, systolic blood pressure, serum albumin, INR, lactate levels, and refractory hypotension. A score of 3 or more is considered high-risk. Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients.
The REDS score includes the following variables, each assigned a point value:
Age: ≥ 65 years old (1 point) Altered Mental State: (1 point) Respiratory Rate: ≥ 22 breaths/min (1 point) Systolic Blood Pressure: ≤ 100 mm Hg (1 point) Serum Albumin: ≤ 27 g/L (1 point) INR: ≥ 1.3 (1 point) Lactate: 2.1-3.9 mmol/L (1 point), ≥ 4 mmol/L (3 points) Refractory Hypotension: (2 points for lactate ≤ 2 mmol/L, 3 points for lactate >2 mmol/L)
Interpreting the REDS score:
0-2: Low risk of death 3 or more: High risk of death The REDS score is a useful tool for emergency departments to quickly identify patients who may be at higher risk of mortality from sepsis and need more aggressive or immediate treatment.The quick SOFA (qSOFA) score is a bedside tool used to quickly assess the risk of death or prolonged intensive care unit stay in patients with suspected infection. It uses three criteria: respiratory rate, altered mental status, and systolic blood pressure. A score of 2 or more indicates a higher risk.
qSOFA Criteria:
- Respiratory Rate: 22 breaths per minute or higher.
- Altered Mental Status: A Glasgow Coma Scale score less than 15.
- Systolic Blood Pressure: 100 mmHg or lower.
Scoring:
Each criterion met scores 1 point. A score of 2 or more indicates a higher risk of poor outcome. qSOFA helps identify patients with suspected infection who are likely to have sepsis. It is a rapid assessment tool that can be used in urgent and resource-limited settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will be randomly assigned to two groups: 1) Group A 2)Group B | – | Device: SphygmomanometerPatients will be randomly assigned to two groups: 1. Group A: Initial vital signs upon arrival at ED triage to evaluate the REDS score [ Time Frame: Timepoint 0 (ED triage) Age: ≥ 65 years old (1 point) Altered Mental State: (1 point) [from 1-15] Respiratory Rate: ≥22 breaths/min (1point ) [yes or not] Systolic Blood Pressure: ≤100 mm Hg (1 point) [yes or not] Serum Albumin: ≤27 g/L (1 point) [yes or not] INR: ≥1.3 (1 point)[yes or not] Lactate: 2.1-3.9 mmol/L (1 point), ≥4 mmol/L (3 points) Refractory Hypotension: (2 points for lactate ≤2 mmol/L, 3 points for lactate >2 mmol/L) will be assessed to evaluate the REDS score. 2. Group B: Initial vital signs upon arrival at ED triage to evaluate the qSOFA score [ Time Frame: Timepoint 0 (ED triage) ] . * Respiratory rate per minute * Mental status * Systolic blood pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our goal in this work is to compare the predictive accuracy of the REDS score versus qSOFA in identifying in-hospital mortality among ED patients with suspected sepsis and improving outcomes in ED patients.
Key inclusion criteria (1 listed)
- Adults ≥ 18 y presented to the ED with suspected or confirmed infection, both sex qSOFA criterion met on arrival ≥ 2
Key exclusion criteria (1 listed)
- Patient less than 18 years Incomplete vital sign records upon ED arrival Pregnant patients Those with DNR state Immune compromised patient as leukemia
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 |
|---|---|---|
| SphygmomanometerMercury sphygmomanometer for measuring blood pressure | Device | Patients will be randomly assigned to two groups: 1) Group A 2)Group B |
Primary outcome
Primary outcome
Time frame: 30 day
primary outcome will be mortality during the 30 day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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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.
Bassant said Mousa Associate Prof of Emergency department Faculty of medicine, Study Principal Investigator contact
Mohamed Anwar, Consultant of Anathesia ICU principal investigator
Assiut University
Haitham Mohammed Ahmed, Lecturer of Anesthesia,ICU study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis in ED Patients, run by Assiut University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Nageh mohamed, M.B.B. Ch (+01119618014, mostafanageh999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 30 day). 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 9 Dec 2025.