Clinical trial NCT04890860: Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
Official title: Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Heart Diseases
Heart Failure
Heart Valve Diseases
Keywords: Cardiac surgery
Echocardiography
Right ventricular dysfunction
Doppler
Portal vein Doppler
Ventricular function
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.

Detailed description: In cardiac surgical patients, RV dysfunction is associated with organ hypoperfusion and venous congestion leading to increased morbidity and mortality.

Non-invasive methods used to assess RV function are 2D-echocardiographic measurement of tricuspid annular plane systolic excursion (TAPSE), RV ejection fraction (EF), RV fractional area change (FAC), 3D assessment of RV function, tissue Doppler assessment of velocities, and magnetic resonance imaging (MRI). Though MRI is the gold standard method to assess RV function, it cannot be used in the perioperative period.

In the present prospective observational study, The investigators investigated the association between the pattern of portal venous flow and RV function as assessed by echocardiography in the postoperative period.

Eligibility criteria: Inclusion Criteria:

* More than 18 years old
* Ability to provide an informed consent
* Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.

Exclusion Criteria:

* Insufficient echogenicity

Primary outcomes:
measure: Right ventricular failure
timeFrame: First 24 hours post cardiac surgery
measure: Portal flow measured by Doppler
timeFrame: First 24 hours post cardiac surgery
Secondary outcomes:
measure: Echocardiographic acquisition
timeFrame: First 24 hours post cardiac surgery
measure: Echocardiographic acquisition
timeFrame: First 24 hours post cardiac surgery
measure: Concordance of pulsatile flow assessment
timeFrame: First 24 hours post cardiac surgery
measure: Concordance of RV dysfunction measurements
timeFrame: First 24 hours post cardiac surgery
measure: Preoperative RV dysfunction
timeFrame: 30 days before cardiac surgery
measure: Acute kidney injury
timeFrame: one week after surgery
measure: Cholestasis
timeFrame: one week after surgery
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
Study officials:
References:
citation: Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.
citation: Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623.
citation: Denault AY, Beaubien-Souligny W, Elmi-Sarabi M, Eljaiek R, El-Hamamsy I, Lamarche Y, Chronopoulos A, Lambert J, Bouchard J, Desjardins G. Clinical Significance of Portal Hypertension Diagnosed With Bedside Ultrasound After Cardiac Surgery. Anesth Analg. 2017 Apr;124(4):1109-1115. doi: 10.1213/ANE.0000000000001812.
citation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.