Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery (DVDDP)

• ClinicalTrials.gov Identifier: NCT04890860
• Recruitment Status: Recruiting
• First Posted: May 18, 2021
• Last Update Posted: June 28, 2021
• Sponsor: CMC Ambroise Paré
• Information provided by (Responsible Party): CMC Ambroise Paré

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Complications; Heart Diseases; Heart Failure; Heart Valve Diseases	Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
• Actual Study Start Date: June 15, 2021
• Estimated Primary Completion Date: June 15, 2022
• Estimated Study Completion Date: June 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.	Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass; cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass

Outcome Measures

Primary Outcome Measures :

1. Right ventricular failure [ Time Frame: First 24 hours post cardiac surgery ]
   1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
   2. RV fractional area change below 35%
   3. End-diastole diameter ratio between RV and left ventricle > 0.6
   4. Ratio between S and D wave or inverse D wave in supra-hepatic veins
2. Portal flow measured by Doppler [ Time Frame: First 24 hours post cardiac surgery ]
   flow pulsatility is assessed with the formula = 100 x (Vmax-Vmin)/Vmax. Time frame: First 24 hours post cardiac surgery

Secondary Outcome Measures :

1. Echocardiographic acquisition [ Time Frame: First 24 hours post cardiac surgery ]

   Feasability of all measurements (RV failure with the 4 criteria:

   1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
   2. RV fractional area change below 35%
   3. End-diastole diameter ratio between RV and left ventricle > 0.6
   4. Ratio between S and D wave or inverse D wave in supra-hepatic veins)
2. Echocardiographic acquisition [ Time Frame: First 24 hours post cardiac surgery ]
   Feasability of all measurements (RV failure with the portal flow with Doppler)
3. Concordance of pulsatile flow assessment [ Time Frame: First 24 hours post cardiac surgery ]
   Concordance of repeated measurements of the venous portal flow Time frame: First 24 hours post cardiac surgery
4. Concordance of RV dysfunction measurements [ Time Frame: First 24 hours post cardiac surgery ]

   Concordance of repeated measurements of :

   1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
   2. RV fractional area change below 35%
   3. End-diastole diameter ratio between RV and left ventricle > 0.6
   4. Ratio between S and D wave or inverse D wave in supra-hepatic veins
5. Preoperative RV dysfunction [ Time Frame: 30 days before cardiac surgery ]

   As defined

   1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
   2. RV fractional area change below 35%
   3. End-diastole diameter ratio between RV and left ventricle > 0.6
   4. Ratio between S and D wave or inverse D wave in supra-hepatic veins
6. Acute kidney injury [ Time Frame: one week after surgery ]
   defined by KDIGO criteria as creatininemia elevation above > 26 micromol/L during the first 48 hours or +50% during the first week, oliguria with urine output less than 0.5 mL/kg/h during 6 hours.
7. Cholestasis [ Time Frame: one week after surgery ]
   Conjugate bilirubin elevation above 12 mmol/L

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

CMC Ambroise Paré; Recruiting

Neuilly-sur-Seine, France, 92200

Contact: NGUYEN Lee, MD,PhD +33 1 46 41 50 79 recherche@clinique-a-pare.fr

Sponsors and Collaborators

CMC Ambroise Paré

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: CMC Ambroise Paré
• ClinicalTrials.gov Identifier: NCT04890860
• Other Study ID Numbers: 2020/08
• First Posted: May 18, 2021
• Last Update Posted: June 28, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CMC Ambroise Paré:

Cardiac surgery; Echocardiography; Right ventricular dysfunction; Doppler; Portal vein Doppler; Ventricular function

Additional relevant MeSH terms:

Heart Diseases; Ventricular Dysfunction; Heart Valve Diseases; Ventricular Dysfunction, Right; Postoperative Complications; Cardiovascular Diseases; Pathologic Processes