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

NCT04890860 | Completed

• 1 other identifier: 2020/08
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Heart Diseases; Heart Failure; Heart Valve Diseases

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Right ventricular failure

  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

  First 24 hours post cardiac surgery

• Portal flow measured by Doppler

  flow pulsatility is assessed with the formula = 100 x (Vmax-Vmin)/Vmax. Time frame: First 24 hours post cardiac surgery

  First 24 hours post cardiac surgery

Secondary Outcomes (7)

• Echocardiographic acquisition

  First 24 hours post cardiac surgery

• Echocardiographic acquisition

  First 24 hours post cardiac surgery

• Concordance of pulsatile flow assessment

  First 24 hours post cardiac surgery

• Concordance of RV dysfunction measurements

  First 24 hours post cardiac surgery

• Preoperative RV dysfunction

  30 days before cardiac surgery

Study Arms (1)

Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.

EXPERIMENTAL

Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass

Interventions

cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass OTHER

cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass

Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Insufficient echogenicity

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

Related Publications (4)

• 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.

  PMID: 19151265 BACKGROUND

• 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.

  PMID: 19151264 BACKGROUND

• 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.

  PMID: 28151822 BACKGROUND

• 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.

  PMID: 20620859 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Heart Diseases; Heart Failure; Heart Valve Diseases; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 18, 2021
• Study Start: June 15, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: March 2, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)