Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department

August 13, 2022 updated by: Mostafa Gaber, Alexandria University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Diagnostic test: passive leg raising test and fluid challenge

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

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

August 3, 2022

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 13, 2022

Last Verified

August 1, 2022

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)?

Undecided

IPD Plan Description

study protocol to be shared later after publishing my scientific paper

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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