Intraoperatory Hemodynamic Monitoring in OLT

NCT06703008 | Recruiting DMC

• 1 other identifier: MEIO21
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

Hemodynamic Monitoring; TEE; Transesophageal Echocardiography; Transoesophageal Echocardiography

Outcome Measures

Primary Outcomes (1)

• Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery

  Cumulative time (in minutes) spent under mean arterial pressure of 65 mmHg.

  From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours).

Secondary Outcomes (10)

• 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 Neurological disturbances

  From the end of surgery for the first 24 hours after withdrawal of sedation in the ICU.

• 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 Incidence of Early Graft Dysfunction / Primary Non Function

  According to definition (up to 7 days after procedure).

• Duration of Post-Reperfusion Syndrome

  First 5 minutes after portal graft anastomosis.

Study Arms (2)

PAC hemodynamic monitoring

NO INTERVENTION

Patients undergoing Liver Transplantation are monitored using the pulmonary artery catheter.

TEE hemodynamic monitoring

EXPERIMENTAL

Patients undergoing Liver Transplantation are monitored using Transesophageal echocardiography and blinded to the pulmonary artery catheter data (insertion of PAC for patient safety is still mandatory, unblinding is allowed if needed for management by the OR anesthesiologist in charge)

Other: TEE hemodynamic monitoring

Interventions

TEE hemodynamic monitoring OTHER

Transesophageal echocardiography monitoring to guide administration of fluids, vasopressor and inotropes during liver transplantation in order to avoid hypotension.

TEE hemodynamic monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCSS AOU di Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Study Officials

• Amedeo Bianchini, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amedeo Bianchini, MD

CONTACT

051 2143101; amedeo.bianchini@aosp.bo.it

Matteo Bianchin, MD

CONTACT

matteo.bianchin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: November 25, 2024
• Study Start: November 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

IT (1)