NCT03702569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

October 4, 2018

Last Update Submit

November 4, 2021

Conditions

Keywords

Volume ExpansionIntensive Care UnitLeft Ventricular ContractilitySpeckle TrackingSTRAIN

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Patients needing a volume expansion

Diagnostic Test: Left ventricular global longitudinal strain measure

Interventions

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

Patients needing a volume expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient older than 18 years hospitalized in neuro-intensive care unit of Bordeaux University Hospital needing volume expansion.

You may qualify if:

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

You may not qualify if:

  • low echogenicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 11, 2018

Study Start

November 20, 2018

Primary Completion

February 17, 2021

Study Completion

February 17, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations