NCT06899867

Brief Summary

Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery. This study aims to compare cardiac index variations between thermodilution and transesophageal echocardiography during liver transplantation. Patients undergo monitoring with both techniques. Measurements are recorded and reported at multiple time points.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiac index variation measured by thermodilution compared with transesophageal echography

    At 4 times of surgery: after starting anesthesia, anhepatic phase, reperfusion and surgical anastomosis of biliary ducts. Data reported : - Cardiac Index before and after end-expiratory test. - Transoesophageal echography measurement of cardiac function

Study Arms (1)

Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon.

* Monitoring transesophageal echography, transpulmonary thermodilution * Measuring cardiac index, preload dependence (end-expiratory test) at 4 steps of surgery * Surgical anastomosis echography * Demographic data, biological data, post operation data

Other: Measure of cardiac index with thermodilution and transesophageal echocardiographyOther: Surgical anastomosis echography

Interventions

At 4 times of surgery, end-expiratory occlusion (EEO) test and measure of cardiac index before and after test with ETO and thermodilution

Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon.

Visualisation of surgical anastomosis through transesophageal echocardiography : stenosis, doppler velocity, collar diameter

Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

age \> 18 years old, undergoing liver transplantation at Croix-Rousse hospital, HCL, Lyon

You may qualify if:

  • liver transplantation
  • adults

You may not qualify if:

  • \- Oesophageal varice ligation \< 14 days
  • Mediastinal radiotherapy
  • Femoral bypass
  • Severe lower extremity artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix Rousse Hsopital

France, Lyon, 69004, France

RECRUITING

MeSH Terms

Interventions

Thermodilution

Intervention Hierarchy (Ancestors)

Indicator Dilution TechniquesInvestigative Techniques

Central Study Contacts

Pr Alice Blet

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

November 27, 2023

Primary Completion

July 1, 2024

Study Completion

November 1, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations