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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890860


Locations
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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
Publications:
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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT04890860    
Other Study ID Numbers: 2020/08
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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