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

Liver Infusion Flow Evaluation With ultraSound for Assessment of Right Ventricular Function: a Single cEnter Cohort Study (LIFESAVE)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06777355
Acronym
LIFESAVE
Enrollment
32
Registered
2025-01-15
Start date
2025-02-24
Completion date
2025-07-04
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Postoperative Complications

Keywords

Liver Infusion Flow, postoperative complication, transthoracic echocardiography, transesophageal echography, Swan-Ganz catheter, portal vein flow, Right Ventricular Dysfunction

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.

Interventions

OTHERTransthoracic 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

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of Portal Vein Flow PulsalityFirst 24 hours post cardiac surgeryMeasured by pulsed Doppler and calculated by the following formula: FP = (Vmax - Vmin) / Vmax × 100.
Right ventricular (RV) function assessementFirst 24 hours post cardiac surgeryRight ventricular (RV) function will be assessed through invasive hemodynamic parameters measured by a pulmonary artery catheter.

Secondary

MeasureTime frameDescription
Renal failureMaximum 30 days post cardiac surgeryAcute kidney injury (AKI) will be defined according to the KDIGO classification.
Liver failureMaximum 30 days post cardiac surgeryAs defined 1. Hyperbilirubinemia \> 2 mg/dL 2. Elevated liver enzymes (AST \> 110 U/L and ALT \> 190 U/L)
Association Between Portal Flow and Postoperative Complications, Including Cardiac TamponadeMaximum 30 days post cardiac surgeryEvaluation of the occurrence of cardiac tamponade.
Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmiasMaximum 30 days post cardiac surgeryEvaluation of the occurrence of ventricular arrhythmias.
RV dysfunctionMaximum 30 days post cardiac surgeryWill be evaluated with echocardiographic parameters: 1. The systolic function is defined by the systolic excursion of the tricuspid annulus (TAPSE) \< 17 mm and/or the systolic velocity of the tricuspid annulus (S' wave) \< 9 cm/s. 2. Diastolic function is assessed by analyzing the tricuspid flow with pulsed tissue Doppler, where the E/A ratio is \< 0.8, or an E/A ratio between 0.8 and 2 associated with an E/E' ratio \> 6, or an E/A ratio \> 2 with a Tei index (TDE) \< 120 ms.
Association between Portal Flow and Postoperative complications, Including mechanical ventilationMaximum 30 days post cardiac surgeryUse of ventilatory support through mechanical ventilation
Association between Portal Flow and Postoperative complications, Including catecholamine administrationMaximum 30 days post cardiac surgeryEvaluation of the occurrence of catecholamine administration
Association between Portal Flow and Postoperative complications, Including mortalityMaximum 30 days post cardiac surgeryMortality in the ICU and in the hospital
Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapyMaximum 30 days post cardiac surgeryEvaluation of the occurrence of the need for initiation of extracorporeal renal replacement therapy (RRT)
Venous congestionMaximum 30 days post cardiac surgeryVenous congestion is measured via central venous catheter, or by echocardiographic findings

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026