An observational study in Postoperative Complications and Heart Failure, sponsored by CMC Ambroise Paré. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by CMC Ambroise Paré · Observational
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.
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 32 is below the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing cardiac surgery with cardiopulmonary bypass, presenting a risk factor for complicated postoperative management due to hemodynamic instability:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing cardiac surgery with cardiopulmonary bypass and presenting at least one risk factor for postoperative complications, including:
Exclusion Criteria:
Patient presenting a confounding factor for altered portal flow:
Patient at risk for pulmonary artery catheter insertion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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
Measure of Portal Vein Flow Pulsality
Measured by pulsed Doppler and calculated by the following formula: FP = (Vmax - Vmin) / Vmax × 100.
Time frame: First 24 hours post cardiac surgery
Right ventricular (RV) function assessement
Right ventricular (RV) function will be assessed through invasive hemodynamic parameters measured by a pulmonary artery catheter.
Time frame: First 24 hours post cardiac surgery
RV dysfunction
Will 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.
Time frame: Maximum 30 days post cardiac surgery
Venous congestion
Venous congestion is measured via central venous catheter, or by echocardiographic findings
Time frame: Maximum 30 days post cardiac surgery
Renal failure
Acute kidney injury (AKI) will be defined according to the KDIGO classification.
Time frame: Maximum 30 days post cardiac surgery
Liver failure
As defined 1. Hyperbilirubinemia \> 2 mg/dL 2. Elevated liver enzymes (AST \> 110 U/L and ALT \> 190 U/L)
Time frame: Maximum 30 days post cardiac surgery
Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade
Evaluation of the occurrence of cardiac tamponade.
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmias
Evaluation of the occurrence of ventricular arrhythmias.
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapy
Evaluation of the occurrence of the need for initiation of extracorporeal renal replacement therapy (RRT)
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mechanical ventilation
Use of ventilatory support through mechanical ventilation
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including catecholamine administration
Evaluation of the occurrence of catecholamine administration
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mortality
Mortality in the ICU and in the hospital
Time frame: Maximum 30 days post cardiac surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Jul 2025, 4 months.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 4 months is below that.
Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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CMC Ambroise Paré