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Completed

NCT Number: NCT03090204

Strain Analysis as a Right Ventricle Contractility Marker

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.

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Key information

Conditions

Systolic Function Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Saint Joseph Saint Luc, Lyon, France

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ultrasound measurements

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
Oct 31, 2019

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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