Sepsis ScoresNCT05107297
Comparison to Early Detect of the Sepsis
An observational study of Sepsis Scores, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis Scores
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all gender entering the emergency deparment from 18 years to 80 years with no acceptance of healthy volunteers .
Who may be able to join
- Age of 18 - 80 years.
- Patients of both genders.
Who cannot join
- Patient refusal .
- Accepts Healthy Volunteers .
- Aged below 18 years
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Sepsis Scores
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality .
Mortality during the 30 day follow-up.
Measured: 30 days
Secondary outcomes (3)
Hospital admission .
Admission to hospital from the Emergency Department.
Measured: Day 0
ICU/HDU admission .
Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department .
Measured: Day 0
Readmission in the ED .
Re-visits to the ED after the index-visit .
Measured: Hour 72, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sepsis ScoresStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hassan Mostafa Abdellah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107297
- Sponsor's protocol ID
- sepsis identification
- Status last verified
- Oct 2021
- First submitted
- 24 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 27649072Usman 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 30470600Bewersdorf 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05107297
- Acronym / sponsor ID
- sepsis identification
- Conditions
- Sepsis Scores
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all gender entering the emergency deparment from 18 years to 80 years with no acceptance of healthy volunteers .
Key inclusion criteria (2 listed)
- Age of 18 - 80 years.
- Patients of both genders.
Key exclusion criteria (3 listed)
- Patient refusal .
- Accepts Healthy Volunteers .
- Aged below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality .
Time frame: 30 days
Mortality during the 30 day follow-up.
3 secondary outcomes
Hospital admission .
Time frame: Day 0
ICU/HDU admission .
Time frame: Day 0
Readmission in the ED .
Time frame: Hour 72, Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 27649072Churpek 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.
- Background: PubMed 30470600Usman 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.
- Background: PubMed 26524675Bewersdorf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Scores, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa H. Mostafa, GP (+201552590309, moustafa.13212250@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality . (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107297, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.