Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation

Liver Transplant; Complications Clinical Trial

— STRAIN ETO  

Official title:

Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037838
• Other study ID #: CRC_GHN_2021_002
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmonary arterial hypertension and ischemia-reperfusion syndrome.

Ventricular dysfunction is an underestimated intraoperative liver transplantation phenomenon while it constitutes a risk factor for peroperative and postoperative morbidity and mortality established that graft function can be compromised through the phenomena of low cardiac output and hepatic congestion.

Also, better analyzing myocardial systolic function during liver transplantation could guide practitioners in the treatments to be undertaken, evaluate their effects and diagnose various complications.

In addition, the usual cardiac output measurement systems (transpulmonary thermodilution techniques and pulse wave contour analysis) are poorly suited to liver transplantation. Frequent variations in blood volume, vasomotor tone and temperature require regular recalibrations and prevent a continuous and reliable estimate of cardiac output.

Thus, the choice of hemodynamic monitoring during liver transplantation performed in our center is transesophageal ultrasound, a semi-invasive method with a favorable benefit-risk ratio in this category of the population. However, analysis of right ventricular systolic function by classical indices is difficult in transesophageal ultrasound for reasons of alignment of the ultrasound shot on the right ventricular. The analysis of left ventricular systolic function is complex due to the sudden variations in volume and the difficulty in carrying out planimetry measurements in real time.

Myocardial strain imaging has been developed in recent years and is widely validated for the assessment of left ventricular contractile function. It was subsequently applied to the exploration of the right ventricular. Its measurement can be performed from recordings on dedicated software.

Thus, the strain could make it possible to better assess myocardial systolic dysfunction in liver per-transplantation from the transesophageal echographic loops recorded in current practice at the different operating times. Strain measurements will be carried out a posteriori from the images which are acquired in a standard way during the operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2021
• Est. primary completion date: April 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 years old and more

• Patients undergoing a liver transplantation

Exclusion Criteria:

• Contraindication to transesophageal ultrasound

• Refusal to participate

• Age <18 years old

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Myocardial Dysfunction

Intervention

Procedure:
• Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation
Longitudinal strain of Left Ventricule and longitudinal strain of Right Ventricule free wall obtained thanks to TransEosophagal Ultrasound performed during the Liver Transplant

Locations

Country	Name	City	State
France	Hopital de la Croix Rousse	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variations of strain	Variations of left ventricular longitudinal strain and right ventricular free wall longitudinal strain obtained with transesophageal ultrasound data during each phase of orthotopic liver transplantation, The primary endpoint is to objective a myocardial dysfunction comparatively to baseline assessment.	The variations will be observed thanks to measurements done before incision, during the dissection phase, during the anhepatic period, during the reperfusion phase, during the biliary reconstruction and finally after the patient closure