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

NCT05849194 | Completed

• 1 other identifier: 0201798
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 .

Conditions

Sepsis

Keywords

Point of care ultrasound; Sepsis; Emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time taken to reach diagnosis in both groups

  8 months

Study Arms (2)

POCUS group

EXPERIMENTAL

Group that will undergo POCUS examination

Diagnostic Test: POCUS examination

Control group

NO INTERVENTION

The group that will not undergo POCUS examination

Interventions

POCUS examination DIAGNOSTIC_TEST

Point of care ultrasound examination

POCUS group

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients admitted to the Emergency Department (ED) of Alexandria Main University Hospital (AMUH) with sepsis.
• Patients presented with septic shock.

You may not qualify if:

• Age less than 18
• Trauma patients.
• Pregnant females.
• Patients with terminal malignancy.
• Patients taking immunosuppressive drugs or chemotherapy.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria main university hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 8, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2023-04

Locations

EG (1)