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Completed

NCT Number: NCT03702569

Speckle-Tracking and Volume Expansion

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.

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Key information

Conditions

Volume Expansion Left Ventricular Contractility Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left ventricular global longitudinal strain measure

Diagnostic Test

Left ventricular global longitudinal strain value measured before and immediately after volume expansion (500mL crystalloid) using speckle tracking images with echocardiography

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Myocardial Effects of Volume Expansion Evaluated Using Speckle-Tracking (STRAIN) in Intensive Care Unit Patients

Acronym: FLUID-STRAIN

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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