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Strain Analysis as a Right Ventricle Contractility Marker

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ClinicalTrials.gov Identifier: NCT03090204
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.

Condition or disease Intervention/treatment Phase
Systolic Function Procedure: ultrasound measurements Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Strain Analysis as a Right Ventricle Contractility Marker
Actual Study Start Date : November 25, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
ultrasound measurements
ultrasound measurements of myocardial deformation of free wall right ventricle during a sharp decline of right ventricle preload induced during a session of Intermittent hemodialysis.
Procedure: ultrasound measurements
ultrasound measurements of myocardial deformation of free wall right ventricle at 4 time points during a session of intermittent hemodialysis : before the intermittent hemodialysis connection, just after starting hemodialysis, after 1 hour of hemodialysis and 5 minutes before restitution




Primary Outcome Measures :
  1. Evaluation of the change in the Longitudinal strain of the free wall right ventricle [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound


Secondary Outcome Measures :
  1. Evaluation of the change in S' right ventricle wave [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  2. Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  3. Evaluation of the change in visual left ventricular ejection fraction (LVEF) [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  4. Evaluation of the change in mitral E wave [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  5. Evaluation of the change in mitral A wave [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  6. Evaluation of the change in wave E ' at the lateral mitral ring [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  7. Evaluation of the change in systolic fraction of pulmonary venous flow [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound

  8. inter individual variability of Longitudinal strain of the free wall right ventricle [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    Each measurement will be performed by two blind operators

  9. intra individual variability of Longitudinal strain of the free wall right ventricle [ Time Frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution ]
    Each measurement will be performed by two blind operators



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years
  • Patients with renal failure treated with intermittent hemodialysis
  • Patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in Article L. 1111-6 of the Public Health Code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study.

Exclusion Criteria:

  • Patients with heart disease (valvular, ischemic, rhythmic)
  • Patients with ejection fraction of left ventricular altered <45%
  • Chronic dialysis patients
  • Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:

    • Pregnant women, parturients or nursing mothers
    • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
    • Minor Patients
    • Major persons who are subject to a legal protection measure or are unable to express their consent
  • Patients not willing to participate in the study
  • Patients not affiliated to a social security

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): NCT03090204


Locations
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France
Hôpital de la Croix Rousse
Lyon, France, 69004
Hopital Saint Joseph Saint Luc
Lyon, France, 69007
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Zoé Schmitt Hôpital de la Croix-Rousse

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03090204     History of Changes
Other Study ID Numbers: 69HCL16-0370
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019

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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 Hospices Civils de Lyon:
strain
myocarditic deformation imaging
right ventricle (RV)
systolic RV function
preload dependence
contractility
intermittent hemodialysis (HDI)
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries