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NCT05037838: STRAIN ETO
Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation
trial testing Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation in Myocardial Dysfunction in 60 participants. Completed in 30 May 2021.
1 April 2021
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 1 November 2020 |
| Primary completion | 1 April 2021 |
| Estimated completion | 30 May 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation
Conditions studied
- Myocardial Dysfunction — all drugs for Myocardial Dysfunction →
- Liver Transplant; Complications — all drugs for Liver Transplant; Complications →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Myocardial Dysfunction or Liver Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05037838
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05037838 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 8 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05037838.
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