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Speckle-Tracking and Volume Expansion (FLUID-STRAIN)

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ClinicalTrials.gov Identifier: NCT03702569
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief Summary:
Volume expansion is the cornerstone of hemodynamic management of patients suffering from circulatory failure. The main objective of volume expansion is to increase stroke volume. This increase in stroke volume is due to myocardial contractility improvement. Nowadays, this improvement cannot be assessed using classical monitoring used at the bedside. The main objective of this study is to evaluate left ventricular contractility using Speckle-Tracking before and after volume expansion in intensive care unit patients, to determine if this technology is more sensitive than previous for left ventricular contractility assessment.

Condition or disease Intervention/treatment
Volume Expansion Left Ventricular Contractility Diagnostic Test: Left ventricular global longitudinal strain measure

Detailed Description:

The main objective of volume expansion is to increase stroke volume. Frank-Starling curve is schematically divided into two portions: a vertical portion which mean that an increase in preload secondary to volume expansion will induce an increase in stroke volume; and a flat portion which mean that a same increase in preload will not induce an increase in stroke volume. Stroke volume increase is due to a myocardial contractility improvement. Nowadays this improvement cannot be assessed using classical monitoring used at the bedside (left ventricular ejection fraction, fractional area changes, etc …). A new method is available to assess left ventricular contractility at the bedside. Two-dimensional speckle tracking images with echocardiography allows one to track a natural myocardial marker within the myocardium by standard transthoracic echocardiography. It provides unique insights into myocardial function such as tissue deformations and strain rate, which is the rate of deformation. This method is more sensitive than classical echographic left ventricular ejection fraction evaluation. Few data are available about the potential interest of speckle tracking to track an improvement of left ventricular contractility following a volume expansion in intensive care unit patients.

This study is observational, prospective in one center. Patients needing a volume expansion will benefit from an echocardiography (stroke volume and longitudinal strain assessment) before and after fluid challenge (500mL of crystalloids).

The follow up will be restricted to the duration of volume expansion. The last data will be collected just after the end of volume expansion.

Study Design
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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Myocardial Effects of Volume Expansion Evaluated Using Speckle-Tracking (STRAIN) in Intensive Care Unit Patients
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : February 17, 2021
Actual Study Completion Date : February 17, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients needing a volume expansion Diagnostic Test: Left ventricular global longitudinal strain measure
Left ventricular global longitudinal strain value measured before and immediately after volume expansion (500mL crystalloid) using speckle tracking images with echocardiography


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular Global Longitudinal Strain [ Time Frame: 3 minutes before the beginning of volume expansion of 500ml of crystalloid ]
    It is calculated using values of longitudinal strain measured in the three-,four-, and two-chamber of the left ventricle of the heart. GLS is expressed as percentage. Strain is a measure of myocardial muscle fiber shortening during contraction and is calculated as the systolic segment shortening between end-systolic (ES) segment length (L) and end-diastolic (ED) length: strain = (-LES - LED)/LED x 100 %.

  2. Left ventricular Global Longitudinal Strain [ Time Frame: 3 minutes after the beginning of volume expansion of 500ml of crystalloid ]
    It is calculated using values of longitudinal strain measured in the three-,four-, and two-chamber of the left ventricle of the heart. GLS is expressed as percentage. Strain is a measure of myocardial muscle fiber shortening during contraction and is calculated as the systolic segment shortening between end-systolic (ES) segment length (L) and end-diastolic (ED) length: strain = (-LES - LED)/LED x 100 %.

  3. Stroke volume [ Time Frame: 3 minutes before the beginning of volume expansion of 500ml of crystalloid ]
  4. Stroke volume [ Time Frame: 3 minutes after the beginning of volume expansion of 500ml of crystalloid ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient older than 18 years hospitalized in neuro-intensive care unit of Bordeaux University Hospital needing volume expansion.
Criteria

Inclusion Criteria:

  • patient older than 18 years
  • hospitalized in neuro-intensive care unit
  • volume expansion indicated by the physician
  • indication of a transthoracic echocardiography

Exclusion Criteria:

  • low echogenicity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702569


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03702569    
Other Study ID Numbers: CHUBX 2018/19
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Volume Expansion
Intensive Care Unit
Left Ventricular Contractility
Speckle Tracking
STRAIN