Liver Transplant; ComplicationsNCT05175534
Contributions of Transesophageal Echocardiography in Liver Transplant Surgery
An observational study of Liver Transplant; Complications, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial summary
The goal of this study is to describe the safety and impact of transesophageal echocardiography in instability episodes during liver transplantation, especially during reperfusion stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Jan 2016to 10 Jun 2020
- 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 liver transplantation
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Susana González Suárez
Barcelona, Catalonia, 08035
Vall d´Hebron Research Institute VHIR
Barcelona, 08035
About this study
Official title: Contributions of Transesophageal Echocardiography During Episodes of Hemodynamic Instability in Liver Transplant Surgery
The goal of this study is to describe the safety and impact of transesophageal echocardiography in instability episodes during liver transplantation, especially during reperfusion stage.
After institutional review board approval, this study was performed in Vall d´Hebron University Hospital including patients undergoing liver transplantation Interventions: peroperative transesophageal echocardiography A transesophageal echocardiography scan was performed in case of hemodynamic instability episodes, and immediately after vascular unclamping.
The investigators registered percentatge of patients with diastolic/systolic dysfunction, hypovolemia, vasodilatation, embolism and percentatge of patients with postreperfusion syndrome
Read the detailed description
A TEE scan was performed in case of hemodynamic instability episodes defined by a decrease of 30% of the mean arterial pressure (MAP) during at least 1 min, and in all patients during immediate graft reperfusion phase and up 30 minutes.
The instability hemodynamic state was classified into four categories: diastolic failure, systolic failure, hypovolemia and vasodilatation.
The diastolic evaluation was performed at ME 4C view using pulsed doppler of the mitral and tricuspid valve at the level of the leaflet tips and tissue Doppler motion of the mitral and tricuspid annulus. The systolic evaluation was performed using tissue Doppler motion of the mitral and tricuspid annulus evaluating S´. Hypovolemia was registered such low filling pressures (mitral lateral E/e´<10 m/s), cardiac index < 2.5 l . min-1 . m-2 and close approximation of the papillary muscles in the TG Mid SAX view. Vasodilatation was registered such low filling pressures (mitral E/e´< 10 m/s) and CI >2.5 l. min-1 . m-2).
An assessment of cardiac filling volumes and contractility, were obtained at two levels: the mid-esophageal four-chamber view (ME 4C) to evaluate the interaction of left and right ventricles and detect possible venous air embolism; and in the trans-gastric mid short axis view (TG mid SAX), to evaluate left ventricular size for the diagnosis of hypovolemia secondary to hemorrhage or altered venous return due to surgical maneuvers on the liver, and segmental wall motion. If the TG mid SAX view was not possible due to the posterior retraction of the stomach during surgery, the ME 4C view, mid-esophageal two chamber view (ME 2C) and mid-esophageal long axis view (ME LAX) was used for the diagnosis of left ventricle systolic dysfunction, and mid-esophageal bicaval view (ME bicaval) was used for the volemia evaluation.
- Conditions
- Liver Transplant; Complications
- Being tested
- monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoringProcedure or surgery
peroperative transesophageal echocardiography for monitoring in liver transplant surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the cardiac alterations observed during reperfusion phase
relationship between cardiac dysfunction and development of post reperfusion syndrome
Measured: during liver transplant
Secondary outcomes (1)
determine the cardiac alterations during episodes of hemodynamic instability
hemodynamic instability was defined as a decrease in the mean arterial pressure (MAP) ≥ 30% from baseline
Measured: during liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start30 Jan 2016
- Primary completion10 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana González-Suárez, MD, PhD, Principal investigator, Vall d´Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175534
- Sponsor's protocol ID
- PR(AG)511/2019
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Suarez S, Corbett M, Hernandez-Martinez A. Impact of graft reperfusion on cardiac function assessed by transesophageal echocardiography during liver transplantation: an observational retrospective study. J Clin Monit Comput. 2024 Apr;38(2):301-311. doi: 10.1007/s10877-023-01110-5. Epub 2023 Nov 30.
PubMed 38032448
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contributions of Transesophageal Echocardiography During Episodes of Hemodynamic Instability in Liver Transplant Surgery
- ClinicalTrials.gov ID
- NCT05175534
- Acronym / sponsor ID
- PR(AG)511/2019
- Conditions
- Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 3 Jan 2022 (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 study is to describe the safety and impact of transesophageal echocardiography in instability episodes during liver transplantation, especially during reperfusion stage.
After institutional review board approval, this study was performed in Vall d´Hebron University Hospital including patients undergoing liver transplantation Interventions: peroperative transesophageal echocardiography A transesophageal echocardiography scan was performed in case of hemodynamic instability episodes, and immediately after vascular unclamping.
The investigators registered percentatge of patients with diastolic/systolic dysfunction, hypovolemia, vasodilatation, embolism and percentatge of patients with postreperfusion syndrome
Detailed description
A TEE scan was performed in case of hemodynamic instability episodes defined by a decrease of 30% of the mean arterial pressure (MAP) during at least 1 min, and in all patients during immediate graft reperfusion phase and up 30 minutes.
The instability hemodynamic state was classified into four categories: diastolic failure, systolic failure, hypovolemia and vasodilatation.
The diastolic evaluation was performed at ME 4C view using pulsed doppler of the mitral and tricuspid valve at the level of the leaflet tips and tissue Doppler motion of the mitral and tricuspid annulus. The systolic evaluation was performed using tissue Doppler motion of the mitral and tricuspid annulus evaluating S´. Hypovolemia was registered such low filling pressures (mitral lateral E/e´<10 m/s), cardiac index < 2.5 l . min-1 . m-2 and close approximation of the papillary muscles in the TG Mid SAX view. Vasodilatation was registered such low filling pressures (mitral E/e´< 10 m/s) and CI >2.5 l. min-1 . m-2).
An assessment of cardiac filling volumes and contractility, were obtained at two levels: the mid-esophageal four-chamber view (ME 4C) to evaluate the interaction of left and right ventricles and detect possible venous air embolism; and in the trans-gastric mid short axis view (TG mid SAX), to evaluate left ventricular size for the diagnosis of hypovolemia secondary to hemorrhage or altered venous return due to surgical maneuvers on the liver, and segmental wall motion. If the TG mid SAX view was not possible due to the posterior retraction of the stomach during surgery, the ME 4C view, mid-esophageal two chamber view (ME 2C) and mid-esophageal long axis view (ME LAX) was used for the diagnosis of left ventricle systolic dysfunction, and mid-esophageal bicaval view (ME bicaval) was used for the volemia evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplantation
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| monitoringperoperative transesophageal echocardiography for monitoring in liver transplant surgery | Procedure or surgery | – |
Primary outcome
determine the cardiac alterations observed during reperfusion phase
Time frame: during liver transplant
relationship between cardiac dysfunction and development of post reperfusion syndrome
1 secondary outcome
determine the cardiac alterations during episodes of hemodynamic instability
Time frame: during liver transplant
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 21 Feb 2023.
- Derived from this study: PubMed 38032448Gonzalez-Suarez S, Corbett M, Hernandez-Martinez A. Impact of graft reperfusion on cardiac function assessed by transesophageal echocardiography during liver transplantation: an observational retrospective study. J Clin Monit Comput. 2024 Apr;38(2):301-311. doi: 10.1007/s10877-023-01110-5. Epub 2023 Nov 30.
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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.
Susana González-Suárez, MD, PhD principal investigator
Vall d´Hebron University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
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 0 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
determine the cardiac alterations observed during reperfusion phase (time frame: during liver transplant). 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 NCT05175534, which also lists 1 linked publication.
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 21 Feb 2023.