Liver TransplantationNCT06899867
Comparing Montiroing Cardiac Index by Transpulmonary Thermodilution and Transesophageal Echocardiography During Liver Transplantation
An observational study of Liver Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Measure of cardiac index with thermodilution and transesophageal echocardiography and Surgical anastomosis echography
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2023to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: age > 18 years old, undergoing liver transplantation at Croix-Rousse hospital, HCL, Lyon
Who may be able to join
- liver transplantation
- adults
Who cannot join
- - Oesophageal varice ligation < 14 days
- Mediastinal radiotherapy
- Femoral bypass
- Severe lower extremity artery disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Croix Rousse Hsopital
France, Lyon, 69004
BLET Alice, MD,PhD, 371239, alice.blet@chu-lyon.fr
About this study
Official title: Is Cardiac Index, Assessed by Transpulmonary Thermodilution, Reliable During Liver Transplantation Compared to Transesophageal Echocardiography : a Monocentric Cohort
Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery.
This study aims to compare cardiac index variations between thermodilution and transesophageal echocardiography during liver transplantation. Patients undergo monitoring with both techniques. Measurements are recorded and reported at multiple time points.
- Conditions
- Liver Transplantation
- Being tested
- Measure of cardiac index with thermodilution and transesophageal echocardiography, Surgical anastomosis echography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of cardiac index with thermodilution and transesophageal echocardiographyOther
At 4 times of surgery, end-expiratory occlusion (EEO) test and measure of cardiac index before and after test with ETO and thermodilution
Surgical anastomosis echographyOther
Visualisation of surgical anastomosis through transesophageal echocardiography : stenosis, doppler velocity, collar diameter
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon. | * Monitoring transesophageal echography, transpulmonary thermodilution
* Measuring cardiac index, preload dependence (end-expiratory test) at 4 steps of surgery
* Surgical anastomosis echography
* Demographic data, biological data, post operation data Receives: Other: Measure of cardiac index with thermodilution and transesophageal echocardiography; Other: Surgical anastomosis echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index variation measured by thermodilution compared with transesophageal echography
Measured: At 4 times of surgery: after starting anesthesia, anhepatic phase, reperfusion and surgical anastomosis of biliary ducts. Data reported : - Cardiac Index before and after end-expiratory test. - Transoesophageal echography measurement of cardiac function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start27 Nov 2023
- Primary completion1 Jul 2024
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899867
- Sponsor's protocol ID
- 24-5431
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cardiac Index, Assessed by Transpulmonary Thermodilution, Reliable During Liver Transplantation Compared to Transesophageal Echocardiography : a Monocentric Cohort
- ClinicalTrials.gov ID
- NCT06899867
- Acronym / sponsor ID
- 24-5431
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Mar 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.
Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery.
This study aims to compare cardiac index variations between thermodilution and transesophageal echocardiography during liver transplantation. Patients undergo monitoring with both techniques. Measurements are recorded and reported at multiple time points.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon. | – | Other: Measure of cardiac index with thermodilution and transesophageal echocardiography, Other: Surgical anastomosis echography* Monitoring transesophageal echography, transpulmonary thermodilution * Measuring cardiac index, preload dependence (end-expiratory test) at 4 steps of surgery * Surgical anastomosis echography * Demographic data, biological data, post operation data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- age > 18 years old, undergoing liver transplantation at Croix-Rousse hospital, HCL, Lyon
Key inclusion criteria (2 listed)
- liver transplantation
- adults
Key exclusion criteria (4 listed)
- - Oesophageal varice ligation < 14 days
- Mediastinal radiotherapy
- Femoral bypass
- Severe lower extremity artery disease
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 |
|---|---|---|
| Measure of cardiac index with thermodilution and transesophageal echocardiographyAt 4 times of surgery, end-expiratory occlusion (EEO) test and measure of cardiac index before and after test with ETO and thermodilution | Other | Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon. |
| Surgical anastomosis echographyVisualisation of surgical anastomosis through transesophageal echocardiography : stenosis, doppler velocity, collar diameter | Other | Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon. |
Primary outcome
Cardiac index variation measured by thermodilution compared with transesophageal echography
Time frame: At 4 times of surgery: after starting anesthesia, anhepatic phase, reperfusion and surgical anastomosis of biliary ducts. Data reported : - Cardiac Index before and after end-expiratory test. - Transoesophageal echography measurement of cardiac function
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
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 Liver Transplantation, run by Hospices Civils de Lyon 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pr Alice Blet (371239, alice.blet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac index variation measured by thermodilution compared with transesophageal echography (time frame: At 4 times of surgery: after starting anesthesia, anhepatic phase, reperfusion and surgical anastomosis of biliary ducts. Data reported : - Cardiac Index before and after end-expiratory test. - Transoesophageal echography measurement of cardiac function). 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 28 Mar 2025.