Liver TransplantationMEIO21NCT06703008
Intraoperatory Hemodynamic Monitoring in OLT
A study testing TEE hemodynamic monitoring in people with Liver Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this clinical trial is to compare two different hemodynamic monitoring techniques during orthotopic liver transplantation. The main question it aims to answer is: if using a different hemodynamic monitoring might help reducing the intraoperative hypotension time. 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?
- TEE hemodynamic monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 1 Jun 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for Liver Transplantation
- Acceptance of informed consent to participate in the study.
Who cannot join
- Bleeding esophageal varices
- Bleeding gastro-esophageal ulcer
- Gastro-esophageal anomalies (congenital, acquired or post-surgical)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matteo Bianchin, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCSS AOU di Bologna
Bologna, Emilia-Romagna, 40138
Amedeo Bianchini, MD
Matteo Bianchin, MD
About this study
Official title: "Monitoraggio Emodinamico Intraoperatorio in OLT"
The goal of this clinical trial is to compare two different hemodynamic monitoring techniques during orthotopic liver transplantation.
The main question it aims to answer is: if using a different hemodynamic monitoring might help reducing the intraoperative hypotension time. Participants will be randomized to one of two arms of hemodynamic monitoring:
- conventional monitoring with pulmonary artery catheter
- monitoring with transesophageal echocardiography Researchers will compare the two groups to see if there is any difference in the intraoperatory hypotension time and in secondary outcomes such as organ dysfunctions or mortality.
Read the detailed description
Intraoperative hypotension is an independent risk factor for the development of complications and postoperative mortality. In non-cardiac surgery, in particular, the time spent under a mean arterial pressure (MAP) of 55 correlates with an increase in myocardial ischemic damage, acute renal failure, and 30-day mortality.
Orthotopic liver transplantation (OLT) is a complex and risky procedure both from a surgical and an anesthesiological standpoint. Difficulties in hemodynamic management arise from the pathophysiological alterations in cirrhotic patients, high-impact surgical procedures (e.g., caval and portal clamping), high bleeding risk, and post-reperfusion syndrome (PRS).
In liver transplantation, the pulmonary artery catheter (PAC) remains the "gold standard" for hemodynamic instability monitoring and is placed in over 90% of patients in the USA.
Transesophageal echocardiography (TEE) is a semi-invasive ultrasound monitoring procedure. As recognized in a recent position paper by the Society for the Advancement of Transplant Anesthesia (SATA), there has been a considerable increase in the use of TEE during OLT in recent years, despite the lack of randomized controlled trials (RCTs) confirming its effectiveness. According to the SATA task force, the increased intraoperative use of TEE is imputable to the chance for a more thorough understanding of hemodynamic pathophysiology and the possibility of identifying new findings, otherwise not identifiable with PAC (cardiac tamponade, gas embolism, intracardiac thrombus, papillary muscle/chordae rupture, left ventricular outflow tract obstruction, etc.). The overall complication rate of TEE in the articles analyzed by SATA was found to be 0.47% compared to 5-10% for PAC complications, thus supporting the safety of the procedure.
Currently, there is a lack of published RCTs comparing these monitoring methods to determine if there is an optimal intraoperative monitoring system during OLT.
The research hypothesis of this study is that TEE monitoring allows for better hemodynamic management during OLT, reducing the duration of hypotension and providing better guidance fo fluid-pharmacological therapy compared to standard monitoring (PAC).
The primary outcome is to compare the impact of two different hemodynamic monitoring systems (TEE and PAC) on intraoperative hemodynamic optimization during OLT.
- Conditions
- Liver Transplantation
- Being tested
- TEE hemodynamic monitoring
- Keywords
- Hemodynamic Monitoring, TEE, Transesophageal Echocardiography, Transoesophageal Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEE hemodynamic monitoringOther
Transesophageal echocardiography monitoring to guide administration of fluids, vasopressor and inotropes during liver transplantation in order to avoid hypotension.
| Study group | Role | What they receive |
|---|---|---|
| PAC hemodynamic monitoring | No intervention | Patients undergoing Liver Transplantation are monitored using the pulmonary artery catheter. |
| TEE hemodynamic monitoring | Experimental | Patients undergoing Liver Transplantation are monitored using Transesophageal echocardiography and blinded to the pulmonary artery catheter data (insertion of PAC for patient safety is still mandatory, unblinding is allowed if needed for management by the OR anesthesiologist in charge) Receives: Other: TEE hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery
Cumulative time (in minutes) spent under mean arterial pressure of 65 mmHg.
Measured: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours).
Secondary outcomes (10)
New Onset Renal Failure
New onset Renal Failure according to KDIGO( Kidney Disease Improving Global Outcomes) Criteria for Acute Renal Failure
Measured: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)
New Onset Neurological disturbances
Cumulative assessement of new-onset delirium, focal neurological disturbances or alteration of Glasgow Coma Scale GCS (from worst value GCS=3 to best value GCS=15 ) compared to the pre-operative status
Measured: From the end of surgery for the first 24 hours after withdrawal of sedation in the ICU.
New Onset Cardiological events
Cumulative outcome of : new onset acute coronary syndromes, ischemic alterations on post-operative EKG, new onset tricuspid insufficiency.
Measured: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)
Cumulative Incidence of Early Graft Dysfunction / Primary Non Function
Cumulative Incidence of Early Graft Dysfunction / Primary Non Function as markers of graft failure.
Measured: According to definition (up to 7 days after procedure).
Duration of Post-Reperfusion Syndrome
Duration of Post-Reperfusion Syndrome defined as hypotension (MAP< 65mmHg) lasting more than 1 minute in the first 5 minutes after portal graft anastomosis.
Measured: First 5 minutes after portal graft anastomosis.
Total amount of fluids administered during surgery
Total amount of crystalloids (in milliliters) administered during surgery
Measured: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)
Cumulative dosage of vasoactive amines administered during surgery
Total amount of norepinephrine and epinephrine (in mcg and in maximum dosage - mcg/kg/h - ) administered during surgery.
Measured: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)
Cumulative incidence of adverse events attributable to the hemodynamic monitoring used
Cumulative incidence of adverse events attributable to the hemodynamic monitoring used
Measured: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)
Duration of ICU admission
Duration of ICU admission in days
Measured: From a minimum of 2 days to a maximum of 3 months
Mortality at 30 and 90 days
Mortality at 30 and 90 days
Measured: 1 month and 3 months after surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (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 IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amedeo Bianchini, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703008
- Sponsor's protocol ID
- MEIO21
- Acronym
- MEIO21
- Status last verified
- Nov 2024
- First submitted
- 30 Aug 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Monitoraggio Emodinamico Intraoperatorio in OLT"
- ClinicalTrials.gov ID
- NCT06703008
- Acronym / sponsor ID
- MEIO21 / MEIO21
- Conditions
- Liver Transplantation
- Keywords
- Hemodynamic Monitoring, TEE, Transesophageal Echocardiography, Transoesophageal Echocardiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Nov 2024 (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.
The goal of this clinical trial is to compare two different hemodynamic monitoring techniques during orthotopic liver transplantation.
The main question it aims to answer is: if using a different hemodynamic monitoring might help reducing the intraoperative hypotension time. Participants will be randomized to one of two arms of hemodynamic monitoring:
- conventional monitoring with pulmonary artery catheter
- monitoring with transesophageal echocardiography Researchers will compare the two groups to see if there is any difference in the intraoperatory hypotension time and in secondary outcomes such as organ dysfunctions or mortality.
Detailed description
Intraoperative hypotension is an independent risk factor for the development of complications and postoperative mortality. In non-cardiac surgery, in particular, the time spent under a mean arterial pressure (MAP) of 55 correlates with an increase in myocardial ischemic damage, acute renal failure, and 30-day mortality.
Orthotopic liver transplantation (OLT) is a complex and risky procedure both from a surgical and an anesthesiological standpoint. Difficulties in hemodynamic management arise from the pathophysiological alterations in cirrhotic patients, high-impact surgical procedures (e.g., caval and portal clamping), high bleeding risk, and post-reperfusion syndrome (PRS).
In liver transplantation, the pulmonary artery catheter (PAC) remains the "gold standard" for hemodynamic instability monitoring and is placed in over 90% of patients in the USA.
Transesophageal echocardiography (TEE) is a semi-invasive ultrasound monitoring procedure. As recognized in a recent position paper by the Society for the Advancement of Transplant Anesthesia (SATA), there has been a considerable increase in the use of TEE during OLT in recent years, despite the lack of randomized controlled trials (RCTs) confirming its effectiveness. According to the SATA task force, the increased intraoperative use of TEE is imputable to the chance for a more thorough understanding of hemodynamic pathophysiology and the possibility of identifying new findings, otherwise not identifiable with PAC (cardiac tamponade, gas embolism, intracardiac thrombus, papillary muscle/chordae rupture, left ventricular outflow tract obstruction, etc.). The overall complication rate of TEE in the articles analyzed by SATA was found to be 0.47% compared to 5-10% for PAC complications, thus supporting the safety of the procedure.
Currently, there is a lack of published RCTs comparing these monitoring methods to determine if there is an optimal intraoperative monitoring system during OLT.
The research hypothesis of this study is that TEE monitoring allows for better hemodynamic management during OLT, reducing the duration of hypotension and providing better guidance fo fluid-pharmacological therapy compared to standard monitoring (PAC).
The primary outcome is to compare the impact of two different hemodynamic monitoring systems (TEE and PAC) on intraoperative hemodynamic optimization during OLT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAC hemodynamic monitoring | No intervention | –Patients undergoing Liver Transplantation are monitored using the pulmonary artery catheter. |
| TEE hemodynamic monitoring | Experimental | Other: TEE hemodynamic monitoringPatients undergoing Liver Transplantation are monitored using Transesophageal echocardiography and blinded to the pulmonary artery catheter data (insertion of PAC for patient safety is still mandatory, unblinding is allowed if needed for management by the OR anesthesiologist in charge) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidate for Liver Transplantation
- Acceptance of informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Bleeding esophageal varices
- Bleeding gastro-esophageal ulcer
- Gastro-esophageal anomalies (congenital, acquired or post-surgical)
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 |
|---|---|---|
| TEE hemodynamic monitoringTransesophageal echocardiography monitoring to guide administration of fluids, vasopressor and inotropes during liver transplantation in order to avoid hypotension. | Other | TEE hemodynamic monitoring |
Primary outcome
Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery
Time frame: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours).
Cumulative time (in minutes) spent under mean arterial pressure of 65 mmHg.
10 secondary outcomes
New Onset Renal Failure
Time frame: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)
New Onset Neurological disturbances
Time frame: From the end of surgery for the first 24 hours after withdrawal of sedation in the ICU.
New Onset Cardiological events
Time frame: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)
Cumulative Incidence of Early Graft Dysfunction / Primary Non Function
Time frame: According to definition (up to 7 days after procedure).
Duration of Post-Reperfusion Syndrome
Time frame: First 5 minutes after portal graft anastomosis.
Total amount of fluids administered during surgery
Time frame: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)
Cumulative dosage of vasoactive amines administered during surgery
Time frame: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)
Cumulative incidence of adverse events attributable to the hemodynamic monitoring used
Time frame: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)
Duration of ICU admission
Time frame: From a minimum of 2 days to a maximum of 3 months
Mortality at 30 and 90 days
Time frame: 1 month and 3 months after surgical procedure.
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 25 Nov 2024.
Related trials for Liver Transplantation
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
RecruitingObservational study
Study of Sleep Quality and Its Specific Determinants During the Care Pathway of a Liver Transplant Patient
Liver Transplantation
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
In-situ vs Ex-situ Liver Preservation
Liver Disease (Alcoholic or Not), Transplantation
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.
Matteo Bianchin, MD contact
Amedeo Bianchini, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEE hemodynamic monitoring in people with Liver Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 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 25 Nov 2024. 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 Italy. 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 Amedeo Bianchini, MD (051 2143101 ext. +39, amedeo.bianchini@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery (time frame: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours).). 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 25 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.