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NCT Number: NCT04890860

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

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.

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Key information

Conditions

Postoperative Complications Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Right ventricular failure

    Time frame: First 24 hours post cardiac surgery

    • systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
    • RV fractional area change below 35%
    • End-diastole diameter ratio between RV and left ventricle > 0.6
    • 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 outcomes

  1. Echocardiographic acquisition

    Time frame: First 24 hours post cardiac surgery

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

    • systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
    • RV fractional area change below 35%
    • End-diastole diameter ratio between RV and left ventricle > 0.6
    • 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 :

    • systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
    • RV fractional area change below 35%
    • End-diastole diameter ratio between RV and left ventricle > 0.6
    • 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

    • systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)
    • RV fractional area change below 35%
    • End-diastole diameter ratio between RV and left ventricle > 0.6
    • 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

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: DVDDP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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