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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
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 3, 2022
Last Updated
August 13, 2022
Sponsor
Alexandria University
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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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