Intraoperatory Hemodynamic Monitoring in OLT

Not Applicable

Recruiting

• Conditions: Liver Transplantation

• Registration Number: NCT06703008
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The goal of this clinical trial is to compare two different hemodynamic monitoring techniques during orthotopic liver transplantation.

The main question it aims to answer is: if using a different hemodynamic monitoring might help reducing the intraoperative hypotension time. Participants will be randomized to one of two arms of hemodynamic monitoring:

* conventional monitoring with pulmonary artery catheter

* monitoring with transesophageal echocardiography Researchers will compare the two groups to see if there is any difference in the intraoperatory hypotension time and in secondary outcomes such as organ dysfunctions or mortality.

Detailed Description

Intraoperative hypotension is an independent risk factor for the development of complications and postoperative mortality. In non-cardiac surgery, in particular, the time spent under a mean arterial pressure (MAP) of 55 correlates with an increase in myocardial ischemic damage, acute renal failure, and 30-day mortality.

Orthotopic liver transplantation (OLT) is a complex and risky procedure both from a surgical and an anesthesiological standpoint. Difficulties in hemodynamic management arise from the pathophysiological alterations in cirrhotic patients, high-impact surgical procedures (e.g., caval and portal clamping), high bleeding risk, and post-reperfusion syndrome (PRS).

In liver transplantation, the pulmonary artery catheter (PAC) remains the "gold standard" for hemodynamic instability monitoring and is placed in over 90% of patients in the USA.

Transesophageal echocardiography (TEE) is a semi-invasive ultrasound monitoring procedure. As recognized in a recent position paper by the Society for the Advancement of Transplant Anesthesia (SATA), there has been a considerable increase in the use of TEE during OLT in recent years, despite the lack of randomized controlled trials (RCTs) confirming its effectiveness. According to the SATA task force, the increased intraoperative use of TEE is imputable to the chance for a more thorough understanding of hemodynamic pathophysiology and the possibility of identifying new findings, otherwise not identifiable with PAC (cardiac tamponade, gas embolism, intracardiac thrombus, papillary muscle/chordae rupture, left ventricular outflow tract obstruction, etc.). The overall complication rate of TEE in the articles analyzed by SATA was found to be 0.47% compared to 5-10% for PAC complications, thus supporting the safety of the procedure.

Currently, there is a lack of published RCTs comparing these monitoring methods to determine if there is an optimal intraoperative monitoring system during OLT.

The research hypothesis of this study is that TEE monitoring allows for better hemodynamic management during OLT, reducing the duration of hypotension and providing better guidance fo fluid-pharmacological therapy compared to standard monitoring (PAC).

The primary outcome is to compare the impact of two different hemodynamic monitoring systems (TEE and PAC) on intraoperative hemodynamic optimization during OLT.

Study Timeline

• Study First Submitted: 2023-08-30
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Candidate for Liver Transplantation
• Acceptance of informed consent to participate in the study.

Exclusion Criteria

• Bleeding esophageal varices
• Bleeding gastro-esophageal ulcer
• Gastro-esophageal anomalies (congenital, acquired or post-surgical)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery	From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours).	Cumulative time (in minutes) spent under mean arterial pressure of 65 mmHg.

Secondary Outcome Measures

Name	Time	Method
New Onset Renal Failure	From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)	New onset Renal Failure according to KDIGO( Kidney Disease Improving Global Outcomes) Criteria for Acute Renal Failure
New Onset Neurological disturbances	From the end of surgery for the first 24 hours after withdrawal of sedation in the ICU.	Cumulative assessement of new-onset delirium, focal neurological disturbances or alteration of Glasgow Coma Scale GCS (from worst value GCS=3 to best value GCS=15 ) compared to the pre-operative status
New Onset Cardiological events	From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)	Cumulative outcome of : new onset acute coronary syndromes, ischemic alterations on post-operative EKG, new onset tricuspid insufficiency.
Cumulative Incidence of Early Graft Dysfunction / Primary Non Function	According to definition (up to 7 days after procedure).	Cumulative Incidence of Early Graft Dysfunction / Primary Non Function as markers of graft failure.
Duration of Post-Reperfusion Syndrome	First 5 minutes after portal graft anastomosis.	Duration of Post-Reperfusion Syndrome defined as hypotension (MAP\< 65mmHg) lasting more than 1 minute in the first 5 minutes after portal graft anastomosis.
Total amount of fluids administered during surgery	From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)	Total amount of crystalloids (in milliliters) administered during surgery
Cumulative dosage of vasoactive amines administered during surgery	From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)	Total amount of norepinephrine and epinephrine (in mcg and in maximum dosage - mcg/kg/h - ) administered during surgery.
Cumulative incidence of adverse events attributable to the hemodynamic monitoring used	From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)	Cumulative incidence of adverse events attributable to the hemodynamic monitoring used
Duration of ICU admission	From a minimum of 2 days to a maximum of 3 months	Duration of ICU admission in days
Mortality at 30 and 90 days	1 month and 3 months after surgical procedure.	Mortality at 30 and 90 days

Trial Locations

Locations (1)

IRCSS AOU di Bologna; 🇮🇹 Bologna, Emilia-Romagna, Italy