Speckle-Tracking and Volume Expansion (FLUID-STRAIN)

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

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.

Study Overview

• Status: Completed
• Conditions: Volume Expansion; Left Ventricular Contractility
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular Global Longitudinal Strain	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 minutes before the beginning of volume expansion of 500ml of crystalloid
Left ventricular Global Longitudinal Strain	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 minutes after the beginning of volume expansion of 500ml of crystalloid
Stroke volume		3 minutes before the beginning of volume expansion of 500ml of crystalloid
Stroke volume		3 minutes after the beginning of volume expansion of 500ml of crystalloid

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): February 17, 2021
• Study Completion (Actual): February 17, 2021

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Speckle Tracking; STRAIN; Volume Expansion; Left Ventricular Contractility
• Other Study ID Numbers: CHUBX 2018/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No