Systolic Function Clinical Trial
Official title:
Strain Analysis as a Right Ventricle Contractility Marker
| Verified date | October 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | December 31, 2017 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital de la Croix Rousse | Lyon | |
| France | Hopital Saint Joseph Saint Luc | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the change in the Longitudinal strain of the free wall right ventricle | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in S' right ventricle wave | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE) | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in visual left ventricular ejection fraction (LVEF) | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in mitral E wave | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in mitral A wave | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in wave E ' at the lateral mitral ring | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | Evaluation of the change in systolic fraction of pulmonary venous flow | 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 | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | inter individual variability of Longitudinal strain of the free wall right ventricle | Each measurement will be performed by two blind operators | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution | |
| Secondary | intra individual variability of Longitudinal strain of the free wall right ventricle | Each measurement will be performed by two blind operators | at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution |