NCT07271329

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 28, 2025

Last Update Submit

November 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

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

    30 day

Study Arms (1)

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

Mercury sphygmomanometer for measuring blood pressure

Patients will be randomly assigned to two groups: 1) Group A 2)Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut

Asyut, Abo Tig, 71641, Egypt

Location

MeSH Terms

Interventions

Sphygmomanometers

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Officials

  • Mohamed Anwar, Consultant of Anathesia ICU

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Haitham Mohammed Ahmed, Lecturer of Anesthesia,ICU

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mostafa Nageh mohamed, M.B.B. Ch

CONTACT

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

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Emergency Department

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 9, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

December 9, 2025

Record last verified: 2025-11

Locations