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

NCT ID: NCT07271329

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-15

Brief 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.

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

Conditions

Sepsis in ED Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Sphygmomanometer

Intervention Type: DEVICE

Mercury sphygmomanometer for measuring blood pressure

Interventions

Sphygmomanometer

Mercury sphygmomanometer for measuring blood pressure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

MN MohamedHussin

Resident at Emergency Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Anwar, Consultant of Anathesia ICU

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Haitham Mohammed Ahmed, Lecturer of Anesthesia,ICU

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut

Asyut, Abo Tig, Egypt

Countries

Egypt

Central Contacts

Mostafa Nageh mohamed, M.B.B. Ch

Role: CONTACT

mostafanageh999@gmail.com

+01119618014

Bassant said Mousa Associate Prof of Emergency department Faculty of medicine, Study Principal Investigator

Role: CONTACT

01227062927

Other Identifiers

Reds score versus qSOFA score

Identifier Type: -

Identifier Source: org_study_id