Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
Primary Purpose
Shock
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
passive leg raising test and fluid challenge
Sponsored by

About this trial
This is an interventional diagnostic trial for Shock
Eligibility Criteria
Inclusion Criteria:
- shocked patient with impaired cardiac contractility
Exclusion Criteria:
- Trauma patients.
- Patient with unstable arrhythmias.
- Patients with lower limb amputation.
- Mechanically ventilated patients.
- Patients with prosthetic aortic valve.
- Patients less than 18 years old
- Pregnant.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
shocked patient with impaired cardiac contractility
Arm Description
Outcomes
Primary Outcome Measures
LVOT VTI variability
variability of LVOT VTI to determine fluid responsiveness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05488730
Brief Title
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
Official Title
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Yes
5. Study Description
Brief Summary
fluid therapy is one of the cornerstones in the management of shock but may result in iatrogenic fluid overload .The aim of this study was to assess the role of echocardiography in guiding fluid therapy in shocked patients with impaired cardiac contractility using straight leg raising test ,Inferior vena-cava collapsability index and Doppler imaging in Emergency Department in Alexandria main university hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
shocked patient with impaired cardiac contractility
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
passive leg raising test and fluid challenge
Intervention Description
Shocked patients were subjected to echocardiographic examination if (EF <52%) .baseline LVOT VTI was obtained Then IVC scanning was done through subcostal Window and using M-mode the minimum and the maximum diameters were measured then the collapsibility index was calculated
Then passive leg raising test was done Patients who tolerated the PLR test and did not develop clinical or lung ultrasound signs of fluid overload (lung congestion) were given IV fluid bolus (250 ml normal saline) over 10 minutes followed by measurement of LVOT VTI.
Patients who did not tolerate PLR test or developed clinical or lung ultrasound signs of fluid overload (lung congestion) during PLR test were excluded from the third step (fluid challenge).
The differentiating factor used to allocate patient in which group (non-responder or responder) was LVOT VTI variability after fluid challenge (our gold standard to assess fluid responsiveness).
Primary Outcome Measure Information:
Title
LVOT VTI variability
Description
variability of LVOT VTI to determine fluid responsiveness
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
shocked patient with impaired cardiac contractility
Exclusion Criteria:
Trauma patients.
Patient with unstable arrhythmias.
Patients with lower limb amputation.
Mechanically ventilated patients.
Patients with prosthetic aortic valve.
Patients less than 18 years old
Pregnant.
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
study protocol to be shared later after publishing my scientific paper
Learn more about this trial
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
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