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:
Condition or disease | Intervention/treatment | Phase |
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Coronary Surgery | Device: Pressure/Volume Combination Catheter Device: Transthoracic echocardiography Device: Transesophageal echocardiogram | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation |
Actual Study Start Date : | November 13, 2018 |
Actual Primary Completion Date : | January 16, 2020 |
Actual Study Completion Date : | January 16, 2020 |
Arm | Intervention/treatment |
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Experimental: Elective coronary surgery
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.
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Device: Pressure/Volume Combination Catheter
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.
Device: Transthoracic echocardiography 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).
Device: Transesophageal echocardiogram 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.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
CHU Brugmann | |
Brussels, Belgium, 1020 |
Principal Investigator: | Charlotte Leclercq, MD | CHU Brugmann |
Tracking Information | |||||
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First Submitted Date ICMJE | April 17, 2019 | ||||
First Posted Date ICMJE | April 19, 2019 | ||||
Last Update Posted Date | January 18, 2020 | ||||
Actual Study Start Date ICMJE | November 13, 2018 | ||||
Actual Primary Completion Date | January 16, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation | ||||
Official Title ICMJE | Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation | ||||
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:
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Coronary Surgery | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Elective coronary surgery
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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
9 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Actual Study Completion Date ICMJE | January 16, 2020 | ||||
Actual Primary Completion Date | January 16, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03922178 | ||||
Other Study ID Numbers ICMJE | CHUB-Leclercq | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pierre Wauthy, Brugmann University Hospital | ||||
Study Sponsor ICMJE | Pierre Wauthy | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Brugmann University Hospital | ||||
Verification Date | January 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |