Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Surgery

NCT ID: NCT06777355

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-24

Study Completion Date

2025-07-04

Brief Summary

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Right ventricular dysfunction (RVD) after cardiac surgery is associated with ischemia and myocardial injury. While echocardiographic measures like Tricuspid Annular Plane Systolic Excursion (TAPSE) are frequently used to assess ventricular function, they have limitations in terms of accuracy. The pulmonary artery catheter remains the gold standard for assessing RVD.

This dysfunction is associated with an increased risk of both renal and hepatic failure, complications that significantly affect patient outcomes. Doppler ultrasound has emerged as a valuable tool in predicting these complications, particularly in monitoring portal circulation and hepatic perfusion.

This study aims to explore the association between portal flow pulsatility and RVD after cardiac surgery.

Detailed Description

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The postoperative right ventricular dysfunction (RVD) after cardiac surgery has been described since the 1990s. It is associated to various pathophysiological mechanisms, including ischemia from prolonged aortic clamping, cardioplegia defects, myocardial injury, and ischemia-reperfusion phenomena.

Many studies have observed reduced right ventricular function intraoperatively through transthoracic echocardiographic parameters like TAPSE, fractional area change, and longitudinal strain. However, accurately assessing RVD is challenging, as these parameters can be affected post-surgery without indicating true ventricular failure.

In this context, obtaining reliable and robust invasive hemodynamic measurements is crucial for accurate assessment of RVD.

The pulmonary artery catheter (PAC), or Swan-Ganz catheter remains the gold standard, providing precise information on right ventricular systolic and diastolic function, pulmonary artery pressures, left ventricular end-diastolic pressure, venous oxygen saturation, and cardiac output.

In cardiac surgery, venous congestion resulting from right ventricular dysfunction is closely associated with increased mortality, leading to renal and hepatic failure. Tools like Doppler ultrasound (of renal, portal, and hepatic veins) can predict renal failure risk.

Researchers developed the VEXUS score in 2020 to assess this risk, and recent research found an association between 50% portal flow pulsatility and RVD.

However, some aspects remain to be clarified, such as the significant association between portal venous flow pulsatility and altered TAPSE.

This prospective study aims to examine the association between portal flow pulsatility and right ventricular dysfunction after cardiac surgery.

Conditions

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Postoperative Complications Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Transthoracic and Transesophageal echography within 24 hours post cardiac surgery

Measurement of portal flow velocity using transthoracic echography, as well as measurement of the superior vena cava via transesophageal echography for predicting right ventricular dysfunction.

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery

Intervention Type OTHER

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery in patients at risk for postoperative complications

Interventions

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Transthoracic and Transesophageal echography within 24 hours post cardiac surgery

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery in patients at risk for postoperative complications

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient aged at least 18 years
* Patients undergoing cardiac surgery with cardiopulmonary bypass and presenting at least one risk factor for postoperative complications, including:

* Patient over 60 years old
* Preoperative left ventricular ejection fraction (LVEF) \< 50%
* Surgery involving both coronary artery bypass grafting and valve procedures
* Mitral valve surgery
* Preoperative creatinine clearance less than 30 ml/min
* Patient having signed the informed consent form in accordance with regulations
* Patient covered by social security or an equivalent healthcare system

Exclusion Criteria

* Patient presenting a confounding factor for altered portal flow:

* Tricuspid regurgitation greater than grade 2
* Known cirrhosis
* Patient with intrahepatic arteriovenous malformations
* Patient at risk for pulmonary artery catheter insertion:

* Tricuspid valve surgery
* Pacemaker or implantable cardioverter-defibrillator in place
* Patient with an esophageal tract abnormalities contraindicating transesophageal echocardiography (TEE)
* Pregnant or breastfeeding women
* Patient unable to understand the information provided
* Patient under guardianship, curatorship, or legal protection
* Patients deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2024/04

Identifier Type: -

Identifier Source: org_study_id

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