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Clinical Trials/NCT04890860
NCT04890860
Completed
N/A

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

CMC Ambroise Paré1 site in 1 country70 target enrollmentJune 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
CMC Ambroise Paré
Enrollment
70
Locations
1
Primary Endpoint
Right ventricular failure
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
August 11, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
CMC Ambroise Paré
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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

  • 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)
  • Acute kidney injury(one week after surgery)
  • Cholestasis(one week after surgery)

Study Sites (1)

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