Clinical trial NCT05107297: Comparison to Early Detect of the Sepsis
Official title: Comparison of National Early Warning Score (NEWS) & Sepsis Patient Evaluation in the Emergency Department (SPEED) for The Early Identification of Sepsis in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis Scores
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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 .

Brief 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 .

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient refusal .
* Accepts Healthy Volunteers .
* Aged below 18 years

Primary outcomes:
measure: Mortality .
timeFrame: 30 days
Secondary outcomes:
measure: Hospital admission .
timeFrame: Day 0
measure: ICU/HDU admission .
timeFrame: Day 0
measure: Readmission in the ED .
timeFrame: Hour 72, Day 30
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.