An interventional study of cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass in Postoperative Complications, Heart Diseases and Heart Failure, sponsored by CMC Ambroise Paré. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Other
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.
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 70 is below the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 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
Time frame: First 24 hours post cardiac surgery
Echocardiographic acquisition
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)
Time frame: First 24 hours post cardiac surgery
Echocardiographic acquisition
Feasability of all measurements (RV failure with the portal flow with Doppler)
Time frame: First 24 hours post cardiac surgery
Concordance of pulsatile flow assessment
Concordance of repeated measurements of the venous portal flow Time frame: First 24 hours post cardiac surgery
Time frame: First 24 hours post cardiac surgery
Concordance of RV dysfunction measurements
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
Time frame: First 24 hours post cardiac surgery
Preoperative RV dysfunction
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
Time frame: 30 days before cardiac surgery
Acute kidney injury
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.
Time frame: one week after surgery
Cholestasis
Conjugate bilirubin elevation above 12 mmol/L
Time frame: one week after surgery
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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CMC Ambroise Paré