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Not yet recruitingNCT07271329Updated Dec 9, 2025

REDS SCORE VERSUS qSOFA SCORE to Predict Mortality in Patients With Suspected Sepsis

An observational study in Sepsis in ED Patients, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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 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:

  1. Respiratory Rate: 22 breaths per minute or higher.
  2. Altered Mental Status: A Glasgow Coma Scale score less than 15.
  3. 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

02

Conditions studied

  • Sepsis in ED Patients
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Adults ≥ 18 y presented to the ED with suspected or confirmed infection, both sex qSOFA criterion met on arrival ≥ 2

Exclusion criteria

Exclusion Criteria:

  • Patient less than 18 years Incomplete vital sign records upon ED arrival Pregnant patients Those with DNR state Immune compromised patient as leukemia
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Sphygmomanometer

Interventions

  • DeviceSphygmomanometer

    Mercury sphygmomanometer for measuring blood pressure

06

What researchers measure

Primary outcomes

  1. Primary outcome

    primary outcome will be mortality during the 30 day follow-up

    Time frame: 30 day

07

Study locations

1 site
  • Assiut
    Asyut, Abo Tig 71641, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07271329
Lead sponsor
Assiut University
Responsible party
MN MohamedHussin (Resident at Emergency Department, Assiut University) — Principal investigator
First posted
Dec 9, 2025
Start date
Dec 2025 (estimated)
Primary completion
Nov 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Dec 9, 2025

Study contacts

Mostafa Nageh mohamed, M.B.B. Ch
Contact
mostafanageh999@gmail.com
+01119618014
Bassant said Mousa Associate Prof of Emergency department Faculty of medicine, Study Principal Investigator
Contact
01227062927
Mohamed Anwar, Consultant of Anathesia ICU
principal investigator · Assiut University
Haitham Mohammed Ahmed, Lecturer of Anesthesia,ICU
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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