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

Primary Purpose

Sepsis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
POCUS examination
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Point of care ultrasound, Sepsis, Emergency department

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    POCUS group

    Control group

    Arm Description

    Group that will undergo POCUS examination

    The group that will not undergo POCUS examination

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    July 18, 2023
    Sponsor
    Alexandria University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05849194
    Brief Title
    Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department
    Official Title
    Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alexandria University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis
    Keywords
    Point of care ultrasound, Sepsis, Emergency department

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    POCUS group
    Arm Type
    Experimental
    Arm Description
    Group that will undergo POCUS examination
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The group that will not undergo POCUS examination
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    POCUS examination
    Intervention Description
    Point of care ultrasound examination
    Primary Outcome Measure Information:
    Title
    Diagnostic accuracy of POCUS approach compared with the definitive diagnosis.
    Description
    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.
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    Time taken to reach diagnosis in both groups
    Description
    Evaluation of the difference between two groups regarding time taken to reach diagnosis
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa Mohamed Mustafa
    Phone
    01102305027
    Ext
    +20
    Email
    asmaamohamed697@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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