Clinical trial NCT06777355: Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Surgery
Official title: Liver Infusion Flow Evaluation With ultraSound for Assessment of Right Ventricular Function: a Single cEnter Cohort Study (LIFESAVE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Heart Failure
Keywords: Liver Infusion Flow
postoperative complication
transthoracic echocardiography
transesophageal echography
Swan-Ganz catheter
portal vein flow
Right Ventricular Dysfunction
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery with cardiopulmonary bypass, presenting a risk factor for complicated postoperative management due to hemodynamic instability:

* Patients over 60 years old
* Preoperative left ventricular ejection fraction (LVEF) \< 50%
* Surgery involving coronary artery bypass grafting and valve surgery
* Mitral valve surgery
* Preoperative creatinine clearance less than 30 ml/min

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure of Portal Vein Flow Pulsality
timeFrame: First 24 hours post cardiac surgery
measure: Right ventricular (RV) function assessement
timeFrame: First 24 hours post cardiac surgery
Secondary outcomes:
measure: RV dysfunction
timeFrame: Maximum 30 days post cardiac surgery
measure: Venous congestion
timeFrame: Maximum 30 days post cardiac surgery
measure: Renal failure
timeFrame: Maximum 30 days post cardiac surgery
measure: Liver failure
timeFrame: Maximum 30 days post cardiac surgery
measure: Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade
timeFrame: Maximum 30 days post cardiac surgery
measure: Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmias
timeFrame: Maximum 30 days post cardiac surgery
measure: Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapy
timeFrame: Maximum 30 days post cardiac surgery
measure: Association between Portal Flow and Postoperative complications, Including mechanical ventilation
timeFrame: Maximum 30 days post cardiac surgery
measure: Association between Portal Flow and Postoperative complications, Including catecholamine administration
timeFrame: Maximum 30 days post cardiac surgery
measure: Association between Portal Flow and Postoperative complications, Including mortality
timeFrame: Maximum 30 days post cardiac surgery
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré Hartmann
state: Ile-de-France
Study officials:
References: