Myocardial DysfunctionSTRAIN ETONCT05037838
Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation
An observational study of Myocardial Dysfunction and Liver Transplant; Complications, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Dysfunction, Liver Transplant; Complications
- What is being tested?
- Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 30 May 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing a liver transplantation
Who may be able to join
- Age of 18 years old and more
- Patients undergoing a liver transplantation
Who cannot join
- Contraindication to transesophageal ultrasound
- Refusal to participate
- Age <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantationProcedure or surgery
Longitudinal strain of Left Ventricule and longitudinal strain of Right Ventricule free wall obtained thanks to TransEosophagal Ultrasound performed during the Liver Transplant
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing a liver transplantation | Patients undergoing a liver transplantation and able to have a transesopahageal ultrasound Receives: Procedure: Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Nov 2020
- Primary completion1 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial DysfunctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037838
- Sponsor's protocol ID
- CRC_GHN_2021_002
- Acronym
- STRAIN ETO
- Status last verified
- Jun 2021
- First submitted
- 31 Aug 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT05037838
- Acronym / sponsor ID
- STRAIN ETO / CRC_GHN_2021_002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing a liver transplantation | – | Procedure: Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantationPatients undergoing a liver transplantation and able to have a transesopahageal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a liver transplantation
Key inclusion criteria (2 listed)
- Age of 18 years old and more
- Patients undergoing a liver transplantation
Key exclusion criteria (3 listed)
- Contraindication to transesophageal ultrasound
- Refusal to participate
- Age <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantationLongitudinal strain of Left Ventricule and longitudinal strain of Right Ventricule free wall obtained thanks to TransEosophagal Ultrasound performed during the Liver Transplant | Procedure or surgery | Patient undergoing a liver transplantation |
Primary outcome
variations of strain
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No. The individual participant data will not be shared
Related trials for Myocardial Dysfunction
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Dysfunction and Liver Transplant; Complications, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variations of strain (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.