Clinical trial NCT03922178: Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation
Official title: Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Surgery
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. In addition, they are subject to variations induced by post-charge changes caused by the anesthesia, extracorporeal circulation (ECC) and the surgical procedure itself.

Left ventricular failure is frequently measured by alteration of LV contractile properties, and very rarely by alteration of LV compliance. However, both contractility (systolic) and relaxation (diastolic) parameters are important for the left ventricle to perform its function adequately. Left ventricular failure after cardiac surgery with extracorporeal circulation and cardiac arrest under cardioplegia protection is an important and frequently reported complication. The investigator's objectives are to characterize the diastolic hemodynamic mechanisms of this left ventricular failure and to identify predictors of this failure in the postoperative period.

The quantification of the systolic and diastolic functions of the left ventricle by ventricular pressure-volume curves is the technique of reference today, because it allows to determine parameters that are independent of the pre- and post-load conditions. Previous studies using the conductance catheter for the purpose of estimating left ventricular function perioperatively are rare and report conflicting results. In addition, they were mainly intended to measure the systolic function of the left ventricle. Only one reported the diastolic relaxation parameters evaluated by a conductance catheter. This study showed immediately after withdrawal of the extracorporeal circulation a significant alteration of the diastolic relaxation of the left ventricle, but was not interested in its early (kinetic) evolution peroperatively.

The investigator's experience shows that, in the quarter-hour following the weaning of the extracorporeal circulation, a decrease in filling pressures of the left ventricle concomitant with an increase in cardiac output is objectified. These observations are consistent with a significant improvement in left ventricle compliance, but have never been reported.

The objectives of this study are:

* To characterize the left ventricular diastolic failure after withdrawal of the extracorporeal circulation in coronary surgery.
* To identify the kinetics of this early diastolic failure after withdrawal of the extracorporeal circulation.


Eligibility criteria: Inclusion Criteria:

* Patient of the CHU Brugmann Hospital receiving elective coronary surgery.
* Patient in sinusal rhythm before the operation and during the collection of hemodynamic data.
* Patients with conserved left ventricular function (based on left ventricular ejection fraction assessed by preoperative echocardiography and superior to 50%)

Exclusion Criteria:

* Hypertrophic cardiomyopathy (diastolic septal thickness\> 15 mm)
* Heart failure with left ventricular ejection fraction \<50%
* Presence of cardiac valvulopathy, concerning both right and left atrio-ventricular and ventriculo-arterial valves
* Presence of valvular prosthesis
* Congenital heart disease
* Pregnancy
* Participation to another clinical study

Primary outcomes:
measure: Tele-systolic pressure of the left ventricle
timeFrame: Baseline (before extracorporeal circulation is switched on)
measure: Tele-systolic pressure of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is switched on
measure: Tele-systolic pressure of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is stopped
measure: Tele-systolic pressure of the left ventricle
timeFrame: 10 minutes after extracorporeal circulation is stopped
measure: Tele-systolic pressure of the left ventricle
timeFrame: 20 minutes after extracorporeal circulation is stopped
measure: Diastolic pressure of the left ventricle
timeFrame: Baseline (before extracorporeal circulation is switched on)
measure: Diastolic pressure of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is switched on
measure: Diastolic pressure of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is stopped
measure: Diastolic pressure of the left ventricle
timeFrame: 10 minutes after extracorporeal circulation is stopped
measure: Diastolic pressure of the left ventricle
timeFrame: 20 minutes after extracorporeal circulation is stopped
measure: Tele-systolic volume of the left ventricle
timeFrame: Baseline
measure: Tele-systolic volume of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is switched on
measure: Tele-systolic volume of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is stopped
measure: Tele-systolic volume of the left ventricle
timeFrame: 10 minutes after extracorporeal circulation is stopped
measure: Tele-systolic volume of the left ventricle
timeFrame: 20 minutes after extracorporeal circulation is stopped
measure: Diastolic volume of the left ventricle
timeFrame: Baseline
measure: Diastolic volume of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is switched on
measure: Diastolic volume of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is stopped
measure: Diastolic volume of the left ventricle
timeFrame: 10 minutes after extracorporeal circulation is stopped
measure: Diastolic volume of the left ventricle
timeFrame: 20 minutes after extracorporeal circulation is stopped
measure: Ejection volume of the left ventricle
timeFrame: Baseline
measure: Ejection volume of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is switched on
measure: Ejection volume of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is stopped
measure: Ejection volume of the left ventricle
timeFrame: 10 minutes after extracorporeal circulation is stopped
measure: Ejection volume of the left ventricle
timeFrame: 20 minutes after extracorporeal circulation is stopped
measure: Contractility index of the left ventricle
timeFrame: Baseline
measure: Contractility index of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is switched on
measure: Contractility index of the left ventricle
timeFrame: 1 minute after extracorporeal circulation is stopped
measure: Contractility index of the left ventricle
timeFrame: 10 minutes after extracorporeal circulation is stopped
measure: Contractility index of the left ventricle
timeFrame: 20 minutes after extracorporeal circulation is stopped
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Charlotte Leclercq, MD
role: PRINCIPAL_INVESTIGATOR
References: