跳至主要内容
临床试验/NCT06703008
NCT06703008招募中不适用

"Monitoraggio Emodinamico Intraoperatorio in OLT"

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Number of minutes with mean blood pressure (MAP) less than 65mmHg throughout surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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)

干预措施: TEE hemodynamic monitoring (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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.)
  • 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))
  • 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))
  • 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))
  • Duration of ICU admission(From a minimum of 2 days to a maximum of 3 months)
  • Mortality at 30 and 90 days(1 month and 3 months after surgical procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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