IRCSS AOU di Bologna
Bologna, Emilia-Romagna, 40138, Italy
Location status: Recruiting
Location contact
Amedeo Bianchini, MD
PRINCIPAL_INVESTIGATOR
Matteo Bianchin, MD
SUB_INVESTIGATOR
NCT Number: NCT06703008
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bologna, Emilia-Romagna, 40138, Italy
Location status: Recruiting
Amedeo Bianchini, MD
PRINCIPAL_INVESTIGATOR
Matteo Bianchin, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transesophageal echocardiography monitoring to guide administration of fluids, vasopressor and inotropes during liver transplantation in order to avoid hypotension.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: According to definition (up to 7 days after procedure).
Cumulative Incidence of Early Graft Dysfunction / Primary Non Function as markers of graft failure.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: From a minimum of 2 days to a maximum of 3 months
Duration of ICU admission in days
Time frame: 1 month and 3 months after surgical procedure.
Mortality at 30 and 90 days
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
"Monitoraggio Emodinamico Intraoperatorio in OLT"
Acronym: MEIO21
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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