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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849194
• Other study ID #: 0201798
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Alexandria University
• Contact: Asmaa Mohamed Mustafa
• Phone: 01102305027
• Email: asmaamohamed697[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• POCUS examination
Point of care ultrasound examination

Locations

Country	Name	City	State
Egypt	Alexandria main university hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time taken to reach diagnosis in both groups	Evaluation of the difference between two groups regarding time taken to reach diagnosis	8 months