SepsisNCT05849194
Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department
A study testing POCUS examination in people with Sepsis, run by Alexandria University at 1 site in Egypt.
Trial summary
Aim of the study is to determine the diagnostic accuracy of point-of-care ultrasound and to determine its role in sepsis management . Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Sepsis
- What is being tested?
- POCUS examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 31 Jul 2024
- Phase
- Interventional
- 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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the Emergency Department (ED) of Alexandria Main University Hospital (AMUH) with sepsis.
- Patients presented with septic shock.
Who cannot join
- Age less than 18
- Trauma patients.
- Pregnant females.
- Patients with terminal malignancy.
- Patients taking immunosuppressive drugs or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to determine the diagnostic accuracy of point-of-care ultrasound and to determine its role in sepsis management .
Read the detailed description
Two groups of patients will be studied one group will undergo POCUS examination and the other will not undergo POCUS examination then comparison between them will be done regarding accuracy of diagnosis and time taken to reach diagnosis.
- Conditions
- Sepsis
- Being tested
- POCUS examination
- Keywords
- Point of care ultrasound, Sepsis, Emergency department
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUS examinationDiagnostic test
Point of care ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| POCUS group | Experimental | Group that will undergo POCUS examination Receives: Diagnostic Test: POCUS examination |
| Control group | No intervention | The group that will not undergo POCUS examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of POCUS approach compared with the definitive diagnosis.
The study will include two groups of patients, POCUS group that will undergo point of care ultrasound (POCUS)examination in addition to clinical evaluation and laboratory investigations and control group that will not undergo POCUS examination but only undergo clinical evaluation and laboratory investigations. Both groups will be compared regarding proportion of accurate diagnosis (at emergency department)in relation to the final diagnosis that will be obtained after patient undergo further imaging techniques to search for sepsis such as chest X-ray or CT to look for chest infection and CT abdomen to confirm intra-abdominal sepsis.
Unlike trauma, dyspnea and shock up till now there is no validated POCUS protocol to evaluate patients with sepsis.
Measured: 8 months
Secondary outcomes (1)
Time taken to reach diagnosis in both groups
Evaluation of the difference between two groups regarding time taken to reach diagnosis
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849194
- Sponsor's protocol ID
- 0201798
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department
- ClinicalTrials.gov ID
- NCT05849194
- Acronym / sponsor ID
- 0201798
- Conditions
- Sepsis
- Keywords
- Point of care ultrasound, Sepsis, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 May 2023 (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.
Aim of the study is to determine the diagnostic accuracy of point-of-care ultrasound and to determine its role in sepsis management .
Detailed description
Two groups of patients will be studied one group will undergo POCUS examination and the other will not undergo POCUS examination then comparison between them will be done regarding accuracy of diagnosis and time taken to reach diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS group | Experimental | Diagnostic Test: POCUS examinationGroup that will undergo POCUS examination |
| Control group | No intervention | –The group that will not undergo POCUS examination |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients admitted to the Emergency Department (ED) of Alexandria Main University Hospital (AMUH) with sepsis.
- Patients presented with septic shock.
Key exclusion criteria (5 listed)
- Age less than 18
- Trauma patients.
- Pregnant females.
- Patients with terminal malignancy.
- Patients taking immunosuppressive drugs or chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUS examinationPoint of care ultrasound examination | Diagnostic test | POCUS group |
Primary outcome
Diagnostic accuracy of POCUS approach compared with the definitive diagnosis.
Time frame: 8 months
The study will include two groups of patients, POCUS group that will undergo point of care ultrasound (POCUS)examination in addition to clinical evaluation and laboratory investigations and control group that will not undergo POCUS examination but only undergo clinical evaluation and laboratory investigations. Both groups will be compared regarding proportion of accurate diagnosis (at emergency department)in relation to the final diagnosis that will be obtained after patient undergo further imaging techniques to search for sepsis such as chest X-ray or CT to look for chest infection and CT abdomen to confirm intra-abdominal sepsis. Unlike trauma, dyspnea and shock up till now there is no validated POCUS protocol to evaluate patients with sepsis.
1 secondary outcome
Time taken to reach diagnosis in both groups
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POCUS examination in people with Sepsis, run by Alexandria University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of POCUS approach compared with the definitive diagnosis. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2024.