Exploring the link between portal flow and heart function after cardiac surgery
Liver Infusion Flow Evaluation With ultraSound for Assessment of Right Ventricular Function: a Single cEnter Cohort Study (LIFESAVE)
This study is trying to see if changes in blood flow to the liver after heart surgery can help us understand and improve heart function in patients who might have problems with their right ventricle.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CMC Ambroise Paré Academic / other |
| Locations | 1 site (Neuilly-sur-Seine, Ile-de-France) |
| Trial ID | NCT06777355 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between portal flow pulsatility and right ventricular dysfunction (RVD) in patients following cardiac surgery. It utilizes transthoracic and transesophageal echography within 24 hours post-surgery to assess heart function and identify potential postoperative complications. The study aims to enhance the understanding of how portal circulation impacts RVD, which is critical for improving patient outcomes after cardiac procedures. By employing advanced echocardiographic techniques and the pulmonary artery catheter as a gold standard, the research seeks to provide more accurate assessments of RVD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older undergoing cardiac surgery with cardiopulmonary bypass and at least one risk factor for postoperative complications.
Not a fit: Patients with significant tricuspid regurgitation, known cirrhosis, or those at risk for complications from pulmonary artery catheter insertion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of right ventricular dysfunction, potentially reducing the risk of severe postoperative complications.
How similar studies have performed: While the association between portal flow and RVD has been explored, this specific approach using Doppler ultrasound and the VEXUS score is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Neuilly-sur-Seine, Ile-de-France
- CMC Ambroise Paré Hartmann — Neuilly-sur-Seine, Ile-de-France, France (Recruiting)
Study contacts
- Study coordinator: Lee S Nguyen, MD, PhD
- Email: lee.nguyen@clinique-a-pare.fr
- Phone: 0146 418971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.