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Идёт набор NCT06703008

Intraoperatory Hemodynamic Monitoring in OLT

Без фазы С лечением Liver Transplantation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TEE hemodynamic monitoring.
Кому может быть актуально
Состояния в реестре: Liver Transplantation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

"Monitoraggio Emodinamico Intraoperatorio in OLT"

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery [Срок оценки: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours).]
Вторичные конечные точки (10)
  • New Onset Renal Failure [Срок оценки: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)]
  • New Onset Neurological disturbances [Срок оценки: From the end of surgery for the first 24 hours after withdrawal of sedation in the ICU.]
  • New Onset Cardiological events [Срок оценки: 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 [Срок оценки: According to definition (up to 7 days after procedure).]
  • Duration of Post-Reperfusion Syndrome [Срок оценки: First 5 minutes after portal graft anastomosis.]
  • Total amount of fluids administered during surgery [Срок оценки: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)]
  • Cumulative dosage of vasoactive amines administered during surgery [Срок оценки: From incision to end of procedure (for the entire surgical procedure in a period ranging from 0 to 24 hours)]
  • Cumulative incidence of adverse events attributable to the hemodynamic monitoring used [Срок оценки: From the end of the surgical procedure until discharge from hospital (whole duration of Hospital admission, considered within 3 months)]
  • Duration of ICU admission [Срок оценки: From a minimum of 2 days to a maximum of 3 months]
  • Mortality at 30 and 90 days [Срок оценки: 1 month and 3 months after surgical procedure.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Италия · 1 центр
  • IRCSS AOU di Bologna — Bologna

Идентификаторы

NCT: NCT06703008 · MEIO21

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗