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

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Diagnostic Test: POCUS examination

• Registration Number: NCT05849194
• Lead Sponsor: Alexandria University

Brief Summary

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 Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-08
• Study Start: 2023-08-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POCUS group	POCUS examination	Group that will undergo POCUS examination

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of POCUS approach compared with the definitive diagnosis.	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.

Secondary Outcome Measures

Name	Time	Method
Time taken to reach diagnosis in both groups	8 months	Evaluation of the difference between two groups regarding time taken to reach diagnosis

Trial Locations

Locations (1)

Alexandria main university hospital; 🇪🇬 Alexandria, Egypt