Speckle-Tracking and Volume Expansion (FLUID-STRAIN)

November 4, 2021 updated by: University Hospital, Bordeaux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 %.
3 minutes before the beginning of volume expansion of 500ml of crystalloid
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 minutes after the beginning of volume expansion of 500ml of crystalloid
Stroke volume
Time Frame: 3 minutes before the beginning of volume expansion of 500ml of crystalloid
3 minutes before the beginning of volume expansion of 500ml of crystalloid
Stroke volume
Time Frame: 3 minutes after the beginning of volume expansion of 500ml of crystalloid
3 minutes after the beginning of volume expansion of 500ml of crystalloid

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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