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CompletedNCT05175534Updated Feb 21, 2023

Contributions of Transesophageal Echocardiography in Liver Transplant Surgery

An observational study in Liver Transplant; Complications, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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

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.

02

Conditions studied

  • Liver Transplant; Complications
03

In context

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing liver transplantation

Eligibility criteria

Inclusion Criteria: patients undergoing liver transplantation

-

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
32 participants (actual)
Patient registry
No

Interventions

  • Proceduremonitoring

    peroperative transesophageal echocardiography for monitoring in liver transplant surgery

06

What researchers measure

Primary outcomes

  1. determine the cardiac alterations observed during reperfusion phase

    relationship between cardiac dysfunction and development of post reperfusion syndrome

    Time frame: 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

    Time frame: during liver transplant

07

Study locations

2 sites
  • Susana González Suárez
    Barcelona, Cataluña 08035, Spain
  • Vall d´Hebron Research Institute VHIR
    Barcelona, 08035, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05175534
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Responsible party
Sponsor
First posted
Jan 3, 2022
Start date
Jan 30, 2016
Primary completion
May 10, 2020
Completion
Jun 10, 2020
Last update
Feb 21, 2023

Study contacts

Susana González-Suárez, MD, PhD
principal investigator · Vall d´Hebron University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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