- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05175534
Contributions of Transesophageal Echocardiography in Liver Transplant Surgery
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08035
- Vall d´Hebron Research Institute VHIR
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Cataluña
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Barcelona, Cataluña, Spain, 08035
- Susana González Suárez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: patients undergoing liver transplantation
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Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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determine the cardiac alterations observed during reperfusion phase
Time Frame: during liver transplant
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relationship between cardiac dysfunction and development of post reperfusion syndrome
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during liver transplant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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determine the cardiac alterations during episodes of hemodynamic instability
Time Frame: during liver transplant
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hemodynamic instability was defined as a decrease in the mean arterial pressure (MAP) ≥ 30% from baseline
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during liver transplant
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PR(AG)511/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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