Postoperative ComplicationsLIFESAVENCT06777355
Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Surgery
An observational study of Postoperative Complications and Heart Failure, run by CMC Ambroise Paré at 1 site in France.
Trial summary
Right ventricular dysfunction (RVD) after cardiac surgery is associated with ischemia and myocardial injury. While echocardiographic measures like Tricuspid Annular Plane Systolic Excursion (TAPSE) are frequently used to assess ventricular function, they have limitations in terms of accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Heart Failure
- What is being tested?
- Transthoracic and Transesophageal echography within 24 hours post cardiac surgery
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2025to 4 Jul 2025
- Phase
- Observational
- 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
Study population: Patients undergoing cardiac surgery with cardiopulmonary bypass, presenting a risk factor for complicated postoperative management due to hemodynamic instability: * Patients over 60 years old * Preoperative left ventricular ejection fraction (LVEF) < 50% * Surgery involving coronary artery bypass grafting and valve surgery * Mitral valve surgery * Preoperative creatinine clearance less than 30 ml/min
Who may be able to join
- Patient aged at least 18 years
- Patients undergoing cardiac surgery with cardiopulmonary bypass and presenting at least one risk factor for postoperative complications, including:
- Patient over 60 years old
- Preoperative left ventricular ejection fraction (LVEF) < 50%
- Surgery involving both coronary artery bypass grafting and valve procedures
- Mitral valve surgery
Show all 9Show fewer
- Preoperative creatinine clearance less than 30 ml/min
- Patient having signed the informed consent form in accordance with regulations
- Patient covered by social security or an equivalent healthcare system
Who cannot join
- Patient presenting a confounding factor for altered portal flow:
- Tricuspid regurgitation greater than grade 2
- Known cirrhosis
- Patient with intrahepatic arteriovenous malformations
- Patient at risk for pulmonary artery catheter insertion:
- Tricuspid valve surgery
Show all 12Show fewer
- Pacemaker or implantable cardioverter-defibrillator in place
- Patient with an esophageal tract abnormalities contraindicating transesophageal echocardiography (TEE)
- Pregnant or breastfeeding women
- Patient unable to understand the information provided
- Patient under guardianship, curatorship, or legal protection
- Patients deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site
CMC Ambroise Paré Hartmann
Neuilly-sur-Seine, Île-de-France Region, 92200
About this study
Official title: Liver Infusion Flow Evaluation With ultraSound for Assessment of Right Ventricular Function: a Single cEnter Cohort Study (LIFESAVE)
Right ventricular dysfunction (RVD) after cardiac surgery is associated with ischemia and myocardial injury. While echocardiographic measures like Tricuspid Annular Plane Systolic Excursion (TAPSE) are frequently used to assess ventricular function, they have limitations in terms of accuracy. The pulmonary artery catheter remains the gold standard for assessing RVD.
This dysfunction is associated with an increased risk of both renal and hepatic failure, complications that significantly affect patient outcomes. Doppler ultrasound has emerged as a valuable tool in predicting these complications, particularly in monitoring portal circulation and hepatic perfusion.
This study aims to explore the association between portal flow pulsatility and RVD after cardiac surgery.
Read the detailed description
The postoperative right ventricular dysfunction (RVD) after cardiac surgery has been described since the 1990s. It is associated to various pathophysiological mechanisms, including ischemia from prolonged aortic clamping, cardioplegia defects, myocardial injury, and ischemia-reperfusion phenomena.
Many studies have observed reduced right ventricular function intraoperatively through transthoracic echocardiographic parameters like TAPSE, fractional area change, and longitudinal strain. However, accurately assessing RVD is challenging, as these parameters can be affected post-surgery without indicating true ventricular failure.
In this context, obtaining reliable and robust invasive hemodynamic measurements is crucial for accurate assessment of RVD.
The pulmonary artery catheter (PAC), or Swan-Ganz catheter remains the gold standard, providing precise information on right ventricular systolic and diastolic function, pulmonary artery pressures, left ventricular end-diastolic pressure, venous oxygen saturation, and cardiac output.
In cardiac surgery, venous congestion resulting from right ventricular dysfunction is closely associated with increased mortality, leading to renal and hepatic failure. Tools like Doppler ultrasound (of renal, portal, and hepatic veins) can predict renal failure risk.
Researchers developed the VEXUS score in 2020 to assess this risk, and recent research found an association between 50% portal flow pulsatility and RVD.
However, some aspects remain to be clarified, such as the significant association between portal venous flow pulsatility and altered TAPSE.
This prospective study aims to examine the association between portal flow pulsatility and right ventricular dysfunction after cardiac surgery.
- Conditions
- Postoperative Complications, Heart Failure
- Being tested
- Transthoracic and Transesophageal echography within 24 hours post cardiac surgery
- Keywords
- Liver Infusion Flow, postoperative complication, transthoracic echocardiography, transesophageal echography, Swan-Ganz catheter, portal vein flow, Right Ventricular Dysfunction
- Medical subject headings
- Postoperative Complications, Heart Failure, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic and Transesophageal echography within 24 hours post cardiac surgeryOther
Transthoracic and Transesophageal echography within 24 hours post cardiac surgery in patients at risk for postoperative complications
| Study group | Role | What they receive |
|---|---|---|
| Transthoracic and Transesophageal echography within 24 hours post cardiac surgery | Measurement of portal flow velocity using transthoracic echography, as well as measurement of the superior vena cava via transesophageal echography for predicting right ventricular dysfunction. Receives: Other: Transthoracic and Transesophageal echography within 24 hours post cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Portal Vein Flow Pulsality
Measured by pulsed Doppler and calculated by the following formula: FP = (Vmax - Vmin) / Vmax × 100.
Measured: First 24 hours post cardiac surgery
Right ventricular (RV) function assessement
Right ventricular (RV) function will be assessed through invasive hemodynamic parameters measured by a pulmonary artery catheter.
Measured: First 24 hours post cardiac surgery
Secondary outcomes (10)
RV dysfunction
Will be evaluated with echocardiographic parameters:
- The systolic function is defined by the systolic excursion of the tricuspid annulus (TAPSE) < 17 mm and/or the systolic velocity of the tricuspid annulus (S' wave) < 9 cm/s.
- Diastolic function is assessed by analyzing the tricuspid flow with pulsed tissue Doppler, where the E/A ratio is < 0.8, or an E/A ratio between 0.8 and 2 associated with an E/E' ratio > 6, or an E/A ratio > 2 with a Tei index (TDE) < 120 ms.
Measured: Maximum 30 days post cardiac surgery
Venous congestion
Venous congestion is measured via central venous catheter, or by echocardiographic findings
Measured: Maximum 30 days post cardiac surgery
Renal failure
Acute kidney injury (AKI) will be defined according to the KDIGO classification.
Measured: Maximum 30 days post cardiac surgery
Liver failure
As defined
- Hyperbilirubinemia > 2 mg/dL
- Elevated liver enzymes (AST > 110 U/L and ALT > 190 U/L)
Measured: Maximum 30 days post cardiac surgery
Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade
Evaluation of the occurrence of cardiac tamponade.
Measured: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmias
Evaluation of the occurrence of ventricular arrhythmias.
Measured: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapy
Evaluation of the occurrence of the need for initiation of extracorporeal renal replacement therapy (RRT)
Measured: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mechanical ventilation
Use of ventilatory support through mechanical ventilation
Measured: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including catecholamine administration
Evaluation of the occurrence of catecholamine administration
Measured: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mortality
Mortality in the ICU and in the hospital
Measured: Maximum 30 days post cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start24 Feb 2025
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 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
- NCT06777355
- Sponsor's protocol ID
- 2024/04
- Acronym
- LIFESAVE
- Status last verified
- Nov 2025
- First submitted
- 3 Jan 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Infusion Flow Evaluation With ultraSound for Assessment of Right Ventricular Function: a Single cEnter Cohort Study (LIFESAVE)
- ClinicalTrials.gov ID
- NCT06777355
- Acronym / sponsor ID
- LIFESAVE / 2024/04
- Conditions
- Postoperative Complications, Heart Failure
- Keywords
- Liver Infusion Flow, postoperative complication, transthoracic echocardiography, transesophageal echography, Swan-Ganz catheter, portal vein flow, Right Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 15 Jan 2025 (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 dysfunction (RVD) after cardiac surgery is associated with ischemia and myocardial injury. While echocardiographic measures like Tricuspid Annular Plane Systolic Excursion (TAPSE) are frequently used to assess ventricular function, they have limitations in terms of accuracy. The pulmonary artery catheter remains the gold standard for assessing RVD.
This dysfunction is associated with an increased risk of both renal and hepatic failure, complications that significantly affect patient outcomes. Doppler ultrasound has emerged as a valuable tool in predicting these complications, particularly in monitoring portal circulation and hepatic perfusion.
This study aims to explore the association between portal flow pulsatility and RVD after cardiac surgery.
Detailed description
The postoperative right ventricular dysfunction (RVD) after cardiac surgery has been described since the 1990s. It is associated to various pathophysiological mechanisms, including ischemia from prolonged aortic clamping, cardioplegia defects, myocardial injury, and ischemia-reperfusion phenomena.
Many studies have observed reduced right ventricular function intraoperatively through transthoracic echocardiographic parameters like TAPSE, fractional area change, and longitudinal strain. However, accurately assessing RVD is challenging, as these parameters can be affected post-surgery without indicating true ventricular failure.
In this context, obtaining reliable and robust invasive hemodynamic measurements is crucial for accurate assessment of RVD.
The pulmonary artery catheter (PAC), or Swan-Ganz catheter remains the gold standard, providing precise information on right ventricular systolic and diastolic function, pulmonary artery pressures, left ventricular end-diastolic pressure, venous oxygen saturation, and cardiac output.
In cardiac surgery, venous congestion resulting from right ventricular dysfunction is closely associated with increased mortality, leading to renal and hepatic failure. Tools like Doppler ultrasound (of renal, portal, and hepatic veins) can predict renal failure risk.
Researchers developed the VEXUS score in 2020 to assess this risk, and recent research found an association between 50% portal flow pulsatility and RVD.
However, some aspects remain to be clarified, such as the significant association between portal venous flow pulsatility and altered TAPSE.
This prospective study aims to examine the association between portal flow pulsatility and right ventricular dysfunction after cardiac surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transthoracic and Transesophageal echography within 24 hours post cardiac surgery | – | Other: Transthoracic and Transesophageal echography within 24 hours post cardiac surgeryMeasurement of portal flow velocity using transthoracic echography, as well as measurement of the superior vena cava via transesophageal echography for predicting right ventricular dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery with cardiopulmonary bypass, presenting a risk factor for complicated postoperative management due to hemodynamic instability: * Patients over 60 years old * Preoperative left ventricular ejection fraction (LVEF) < 50% * Surgery involving coronary artery bypass grafting and valve surgery * Mitral valve surgery * Preoperative creatinine clearance less than 30 ml/min
Key inclusion criteria (9 listed)
- Patient aged at least 18 years
- Patients undergoing cardiac surgery with cardiopulmonary bypass and presenting at least one risk factor for postoperative complications, including:
- Patient having signed the informed consent form in accordance with regulations
- Patient covered by social security or an equivalent healthcare system
Key exclusion criteria (12 listed)
- Patient presenting a confounding factor for altered portal flow:
- Patient with intrahepatic arteriovenous malformations
- Patient at risk for pulmonary artery catheter insertion:
- Patient with an esophageal tract abnormalities contraindicating transesophageal echocardiography (TEE)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Transthoracic and Transesophageal echography within 24 hours post cardiac surgeryTransthoracic and Transesophageal echography within 24 hours post cardiac surgery in patients at risk for postoperative complications | Other | Transthoracic and Transesophageal echography within 24 hours post cardiac surgery |
Primary outcome
Measure of Portal Vein Flow Pulsality
Time frame: First 24 hours post cardiac surgery
Measured by pulsed Doppler and calculated by the following formula: FP = (Vmax - Vmin) / Vmax × 100.
Right ventricular (RV) function assessement
Time frame: First 24 hours post cardiac surgery
Right ventricular (RV) function will be assessed through invasive hemodynamic parameters measured by a pulmonary artery catheter.
10 secondary outcomes
RV dysfunction
Time frame: Maximum 30 days post cardiac surgery
Venous congestion
Time frame: Maximum 30 days post cardiac surgery
Renal failure
Time frame: Maximum 30 days post cardiac surgery
Liver failure
Time frame: Maximum 30 days post cardiac surgery
Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmias
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapy
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mechanical ventilation
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including catecholamine administration
Time frame: Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mortality
Time frame: Maximum 30 days post cardiac 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 1 Dec 2025.
- 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?
An observational study of Postoperative Complications and Heart Failure, 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 9 inclusion and 12 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 1 Dec 2025. 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?
Measure of Portal Vein Flow Pulsality (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?
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 1 Dec 2025.