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Clinical Trials/NCT03090204
NCT03090204
Completed
Not Applicable

Strain Analysis as a Right Ventricle Contractility Marker

Hospices Civils de Lyon2 sites in 1 country16 target enrollmentNovember 25, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systolic Function
Sponsor
Hospices Civils de Lyon
Enrollment
16
Locations
2
Primary Endpoint
Evaluation of the change in the Longitudinal strain of the free wall right ventricle
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 25, 2016
End Date
December 31, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

  • Evaluation of the change in S' right ventricle wave(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • Evaluation of the change in visual left ventricular ejection fraction (LVEF)(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • Evaluation of the change in mitral E wave(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • Evaluation of the change in mitral A wave(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • Evaluation of the change in wave E ' at the lateral mitral ring(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • Evaluation of the change in systolic fraction of pulmonary venous flow(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • inter individual variability of Longitudinal strain of the free wall right ventricle(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)
  • intra individual variability of Longitudinal strain of the free wall right ventricle(at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution)

Study Sites (2)

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