Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department

Conditions
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Sepsis

Intervention / Treatment
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* Diagnostic Test: POCUS examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients admitted to the Emergency Department (ED) of Alexandria Main University Hospital (AMUH) with sepsis. Patients presented with septic shock. Exclusion Criteria: Age less than 18 Trauma patients. Pregnant females. Patients with terminal malignancy. Patients taking immunosuppressive drugs or chemotherapy.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POCUS group<br>Group that will undergo POCUS examination | Diagnostic Test: POCUS examination<br>* Point of care ultrasound examination<br>|
| No Intervention: Control group<br>The group that will not undergo POCUS examination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to reach diagnosis in both groups | Evaluation of the difference between two groups regarding time taken to reach diagnosis | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point of care ultrasound, Emergency department, Sepsis