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Status unknownNCT05107297Updated Nov 4, 2021

Comparison to Early Detect of the Sepsis

An observational study in Sepsis Scores, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 80 Years
Sex
All
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Study summary

The aim of the study was to identify co-variates associated with 30-day mortality in septic patients admitted to the emergency department in order to improve morbidity \& mortality as a sequence of sepsis in Assiut \& Suez Canal Universities by comparing both scores by utilizing parameters that are readily available .

Read the detailed description

There are a relatively large number of conditions where urgent intervention is required in order to secure the best outcome for the patient. Examples include sepsis, myocardial infarction (MI). Clinical diagnosis of some of these conditions is not always straightforward, but a common theme is that many present with deranged physiology and vital signs. Implementation of an early warning score on arrival at hospital has helped to identify seriously ill patients .

There is a high mortality rate associated with severe infection at all ages Sepsis occurs when life-threatening organ dysfunction is associated with infection.

What is a national early warning score (NEWS)? The following six simple physiological parameters are included in the scoring system: respiratory rate, oxygen saturation, temperature; the normal human body temperature range is typically stated as 36.5-37 °C( ), systolic blood pressure, pulse rate \& level of consciousness.

What is a sepsis patient evaluation in the emergency department (SPEED)? The following simple clinical, physiological and laboratory parameters are included in the scoring system : hypotension (systolic pressure \<90 mmHg) hypothermia (body temperature \<36.0°C) , hypoxemia (pulse oximetry \<90%), low hematocrit (hematocrit \<0.38), Acidosis (blood PH \< 7.35), elevated blood lactate >2.4 mmol/L \& source of infection as pneumonia.

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Conditions studied

  • Sepsis Scores

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03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 120 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

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.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all gender entering the emergency deparment from 18 years to 80 years with no acceptance of healthy volunteers .

Inclusion criteria

  • Age of 18 - 80 years.
  • Patients of both genders.

Exclusion criteria

Exclusion Criteria:

  • Patient refusal .
  • Accepts Healthy Volunteers .
  • Aged below 18 years
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality .

    Mortality during the 30 day follow-up.

    Time frame: 30 days

Secondary outcomes

  1. Hospital admission .

    Admission to hospital from the Emergency Department.

    Time frame: Day 0

  2. ICU/HDU admission .

    Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department .

    Time frame: Day 0

  3. Readmission in the ED .

    Re-visits to the ED after the index-visit .

    Time frame: Hour 72, Day 30

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Churpek MM, Snyder A, Han X, Sokol S, Pettit N, Howell MD, Edelson DP. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911. doi: 10.1164/rccm.201604-0854OC. PubMed 27649072 ↗
  • Usman OA, Usman AA, Ward MA. Comparison of SIRS, qSOFA, and NEWS for the early identification of sepsis in the Emergency Department. Am J Emerg Med. 2019 Aug;37(8):1490-1497. doi: 10.1016/j.ajem.2018.10.058. Epub 2018 Nov 7. PubMed 30470600 ↗
  • Bewersdorf JP, Hautmann O, Kofink D, Abdul Khalil A, Zainal Abidin I, Loch A. The SPEED (sepsis patient evaluation in the emergency department) score: a risk stratification and outcome prediction tool. Eur J Emerg Med. 2017 Jun;24(3):170-175. doi: 10.1097/MEJ.0000000000000344. PubMed 26524675 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05107297
Lead sponsor
Assiut University
Responsible party
Mostafa Hassan Mostafa Abdellah (resident, Assiut University) — Principal investigator
First posted
Nov 4, 2021
Start date
Nov 1, 2021 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Nov 4, 2021

Study contacts

Mostafa H. Mostafa, GP
Contact
moustafa.13212250@med.aun.edu.eg
+201552590309
Fatma A. Abdelaal, professor
Contact
Fatmaabdelal23@yahoo.com
+201113221317

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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