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

NCT06777355 | Completed

• 1 other identifier: 2024/04
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Measure of Portal Vein Flow Pulsality

  Measured by pulsed Doppler and calculated by the following formula: FP = (Vmax - Vmin) / Vmax × 100.

  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.

  First 24 hours post cardiac surgery

Secondary Outcomes (10)

• RV dysfunction

  Maximum 30 days post cardiac surgery

• Venous congestion

  Maximum 30 days post cardiac surgery

• Renal failure

  Maximum 30 days post cardiac surgery

• Liver failure

  Maximum 30 days post cardiac surgery

• Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade

  Maximum 30 days post cardiac surgery

Study Arms (1)

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery

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

Interventions

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery OTHER

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery in patients at risk for postoperative complications

Transthoracic and Transesophageal echography within 24 hours post cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

MeSH Terms

Conditions

Postoperative Complications; Heart Failure; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 15, 2025
• Study Start: February 24, 2025
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)