NCT03922178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

April 17, 2019

Last Update Submit

January 16, 2020

Conditions

Coronary Surgery

Outcome Measures

Primary Outcomes (30)

  • Tele-systolic pressure of the left ventricle

    Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.

    Baseline (before extracorporeal circulation is switched on)

  • Tele-systolic pressure of the left ventricle

    Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.

    1 minute after extracorporeal circulation is switched on

  • Tele-systolic pressure of the left ventricle

    Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.

    1 minute after extracorporeal circulation is stopped

  • Tele-systolic pressure of the left ventricle

    Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.

    10 minutes after extracorporeal circulation is stopped

  • Tele-systolic pressure of the left ventricle

    Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.

    20 minutes after extracorporeal circulation is stopped

  • Diastolic pressure of the left ventricle

    The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.

    Baseline (before extracorporeal circulation is switched on)

  • Diastolic pressure of the left ventricle

    The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.

    1 minute after extracorporeal circulation is switched on

  • Diastolic pressure of the left ventricle

    The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.

    1 minute after extracorporeal circulation is stopped

  • Diastolic pressure of the left ventricle

    The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.

    10 minutes after extracorporeal circulation is stopped

  • Diastolic pressure of the left ventricle

    The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.

    20 minutes after extracorporeal circulation is stopped

  • Tele-systolic volume of the left ventricle

    At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.

    Baseline

  • Tele-systolic volume of the left ventricle

    At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.

    1 minute after extracorporeal circulation is switched on

  • Tele-systolic volume of the left ventricle

    At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.

    1 minute after extracorporeal circulation is stopped

  • Tele-systolic volume of the left ventricle

    At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.

    10 minutes after extracorporeal circulation is stopped

  • Tele-systolic volume of the left ventricle

    At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.

    20 minutes after extracorporeal circulation is stopped

  • Diastolic volume of the left ventricle

    At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.

    Baseline

  • Diastolic volume of the left ventricle

    At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.

    1 minute after extracorporeal circulation is switched on

  • Diastolic volume of the left ventricle

    At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.

    1 minute after extracorporeal circulation is stopped

  • Diastolic volume of the left ventricle

    At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.

    10 minutes after extracorporeal circulation is stopped

  • Diastolic volume of the left ventricle

    At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.

    20 minutes after extracorporeal circulation is stopped

  • Ejection volume of the left ventricle

    The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.

    Baseline

  • Ejection volume of the left ventricle

    The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.

    1 minute after extracorporeal circulation is switched on

  • Ejection volume of the left ventricle

    The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.

    1 minute after extracorporeal circulation is stopped

  • Ejection volume of the left ventricle

    The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.

    10 minutes after extracorporeal circulation is stopped

  • Ejection volume of the left ventricle

    The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.

    20 minutes after extracorporeal circulation is stopped

  • Contractility index of the left ventricle

    Computed by the following formula: (dP/dt max)/P

    Baseline

  • Contractility index of the left ventricle

    Computed by the following formula: (dP/dt max)/P

    1 minute after extracorporeal circulation is switched on

  • Contractility index of the left ventricle

    Computed by the following formula: (dP/dt max)/P

    1 minute after extracorporeal circulation is stopped

  • Contractility index of the left ventricle

    Computed by the following formula: (dP/dt max)/P

    10 minutes after extracorporeal circulation is stopped

  • Contractility index of the left ventricle

    Computed by the following formula: (dP/dt max)/P

    20 minutes after extracorporeal circulation is stopped

Study Arms (1)

Elective coronary surgery

EXPERIMENTAL

The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and anesthesiology wards. Subjects referred for elective coronary surgery will be prospectively included during the length of the study.

Device: Pressure/Volume Combination CatheterDevice: Transthoracic echocardiographyDevice: Transesophageal echocardiogram

Interventions

Pressure/Volume Combination CatheterDEVICE

Hemodynamic data routinely collected and data collected by means of the placement of a Pressure/Volume Combination Catheter (Pressure/Volume Combination Catheter,Leycom,The Netherlands) will be collected simultaneously. The catheter will be placed and held in place as long as the patient is in a position to be assisted by extracorporeal circulation. This means that the placement of the catheter will follow the heparinization of the patient and the placement of the cannulas necessary for the realization of extracorporal circulation. It will be removed from the left ventricular cavity before removal of extra-corporal cannulas.

Elective coronary surgery
Transthoracic echocardiographyDEVICE

A complete transthoracic echocardiography will be performed the day before the surgical procedure, as per standard of care. It will establish the presence of the inclusion and exclusion criteria and evaluate the contractile function of the left ventricle. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).

Elective coronary surgery
Transesophageal echocardiogramDEVICE

A transesophageal echocardiogram will be performed during the cardiac surgery, as per standard of care, using an Acuson Sequoia system (Siemens AG, Germany). It will facilitate the placement of the pressure/volume combination catheter and collect echographic data.

Elective coronary surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

EchocardiographyEchocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Charlotte Leclercq, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director of the CHU Brugmann Hospital

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 19, 2019

Study Start

November 13, 2018

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)