Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperativ… (NCT06777355) | Clinical Trial Compass
CompletedNot Applicable
Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Surgery
France32 participantsStarted 2025-02-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.