- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107297
Comparison to Early Detect of the Sepsis
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mostafa H. Mostafa, GP
- Phone Number: +201552590309
- Email: moustafa.13212250@med.aun.edu.eg
Study Contact Backup
- Name: Fatma A. Abdelaal, professor
- Phone Number: +201113221317
- Email: Fatmaabdelal23@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of 18 - 80 years.
- Patients of both genders.
Exclusion Criteria:
- Patient refusal .
- Accepts Healthy Volunteers .
- Aged below 18 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality .
Time Frame: 30 days
|
Mortality during the 30 day follow-up.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital admission .
Time Frame: Day 0
|
Admission to hospital from the Emergency Department.
|
Day 0
|
|
ICU/HDU admission .
Time Frame: Day 0
|
Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department .
|
Day 0
|
|
Readmission in the ED .
Time Frame: Hour 72, Day 30
|
Re-visits to the ED after the index-visit .
|
Hour 72, Day 30
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sepsis identification
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.