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

Primary Purpose

Postoperative Complications, Heart Diseases, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
Sponsored by
CMC Ambroise Paré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Complications focused on measuring Cardiac surgery, Echocardiography, Right ventricular dysfunction, Doppler, Portal vein Doppler, Ventricular function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CMC Ambroise Paré

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Right ventricular failure
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
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

Secondary Outcome Measures

Echocardiographic acquisition
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)
Echocardiographic acquisition
Feasability of all measurements (RV failure with the portal flow with Doppler)
Concordance of pulsatile flow assessment
Concordance of repeated measurements of the venous portal flow Time frame: First 24 hours post cardiac surgery
Concordance of RV dysfunction measurements
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
Preoperative RV dysfunction
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
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.
Cholestasis
Conjugate bilirubin elevation above 12 mmol/L

Full Information

First Posted
May 3, 2021
Last Updated
March 1, 2023
Sponsor
CMC Ambroise Paré
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1. Study Identification

Unique Protocol Identification Number
NCT04890860
Brief Title
Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
Acronym
DVDDP
Official Title
Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Heart Diseases, Heart Failure, Heart Valve Diseases
Keywords
Cardiac surgery, Echocardiography, Right ventricular dysfunction, Doppler, Portal vein Doppler, Ventricular function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
Intervention Description
cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Right ventricular failure
Description
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
Time Frame
First 24 hours post cardiac surgery
Title
Portal flow measured by Doppler
Description
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
Secondary Outcome Measure Information:
Title
Echocardiographic acquisition
Description
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)
Time Frame
First 24 hours post cardiac surgery
Title
Echocardiographic acquisition
Description
Feasability of all measurements (RV failure with the portal flow with Doppler)
Time Frame
First 24 hours post cardiac surgery
Title
Concordance of pulsatile flow assessment
Description
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
Title
Concordance of RV dysfunction measurements
Description
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
Time Frame
First 24 hours post cardiac surgery
Title
Preoperative RV dysfunction
Description
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
Time Frame
30 days before cardiac surgery
Title
Acute kidney injury
Description
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
Title
Cholestasis
Description
Conjugate bilirubin elevation above 12 mmol/L
Time Frame
one week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CMC Ambroise Paré
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19151265
Citation
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.
Results Reference
background
PubMed Identifier
19151264
Citation
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.
Results Reference
background
PubMed Identifier
28151822
Citation
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.
Results Reference
background
PubMed Identifier
20620859
Citation
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.
Results Reference
background

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

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