- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05488730
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt
- Faculty of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: shocked patient with impaired cardiac contractility
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LVOT VTI variability
Time Frame: 15 minutes
|
variability of LVOT VTI to determine fluid responsiveness
|
15 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Echo in fluid therapy 2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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