- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05037838
Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation (STRAIN ETO)
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Rhone Alpes
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Lyon, Rhone Alpes, France, 69004
- Hôpital de La Croix Rousse
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Patient undergoing a liver transplantation
Patients undergoing a liver transplantation and able to have a transesopahageal ultrasound
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Longitudinal strain of Left Ventricule and longitudinal strain of Right Ventricule free wall obtained thanks to TransEosophagal Ultrasound performed during the Liver Transplant
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
variations of strain
Délai: 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
|
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.
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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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CRC_GHN_2021_002
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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