Comparison to Early Detect of the Sepsis

October 24, 2021 updated by: Mostafa Hassan Mostafa Abdellah, Assiut University

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

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 .

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 .

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • sepsis identification

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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