Postoperative ComplicationsDVDDPNCT04890860
Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
A study testing cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass in people with Postoperative Complications and Heart Diseases, run by CMC Ambroise Paré at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Heart Diseases, Heart Failure
- What is being tested?
- cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years old
- Ability to provide an informed consent
- Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.
Who cannot join
- Insufficient echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
- Keywords
- Cardiac surgery, Echocardiography, Right ventricular dysfunction, Doppler, Portal vein Doppler, Ventricular function
- Medical subject headings
- Postoperative Complications, Heart Diseases, Heart Failure, Heart Valve Diseases, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypassOther
cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass. | Experimental | Not described Receives: Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: First 24 hours post cardiac surgery
Secondary outcomes (7)
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)
Measured: First 24 hours post cardiac surgery
Echocardiographic acquisition
Feasability of all measurements (RV failure with the portal flow with Doppler)
Measured: 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
Measured: 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
Measured: First 24 hours post cardiac surgery
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
Measured: 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.
Measured: one week after surgery
Cholestasis
Conjugate bilirubin elevation above 12 mmol/L
Measured: one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start15 Jun 2021
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890860
- Sponsor's protocol ID
- 2020/08
- Acronym
- DVDDP
- Status last verified
- Jun 2021
- First submitted
- 3 May 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19151265Haddad 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.
PubMed 19151264Denault 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.
PubMed 28151822Rudski 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.
PubMed 20620859
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04890860
- Acronym / sponsor ID
- DVDDP / 2020/08
- Keywords
- Cardiac surgery, Echocardiography, Right ventricular dysfunction, Doppler, Portal vein Doppler, Ventricular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass. | Experimental | Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 18 years old
- Ability to provide an informed consent
- Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- Insufficient echogenicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypasscardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass | Other | Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass. |
Primary outcome
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
7 secondary outcomes
Echocardiographic acquisition
Time frame: First 24 hours post cardiac surgery
Echocardiographic acquisition
Time frame: First 24 hours post cardiac surgery
Concordance of pulsatile flow assessment
Time frame: First 24 hours post cardiac surgery
Concordance of RV dysfunction measurements
Time frame: First 24 hours post cardiac surgery
Preoperative RV dysfunction
Time frame: 30 days before cardiac surgery
Acute kidney injury
Time frame: one week after surgery
Cholestasis
Time frame: one week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 19151265Haddad 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.
- Background: PubMed 19151264Haddad 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.
- Background: PubMed 28151822Denault 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.
- Background: PubMed 20620859Rudski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass in people with Postoperative Complications and Heart Diseases, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular failure (time frame: First 24 hours post cardiac surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890860, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.