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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05175534
Other study ID # PR(AG)511/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2016
Est. completion date June 10, 2020

Study information

Verified date February 2023
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 10, 2020
Est. primary completion date May 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: patients undergoing liver transplantation - Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
monitoring
peroperative transesophageal echocardiography for monitoring in liver transplant surgery

Locations

Country Name City State
Spain Susana González Suárez Barcelona Cataluña
Spain Vall d´Hebron Research Institute VHIR Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary determine the cardiac alterations observed during reperfusion phase relationship between cardiac dysfunction and development of post reperfusion syndrome during liver transplant
Secondary 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 during liver transplant
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