跳至主要内容
临床试验/NCT03776396
NCT03776396已完成不适用

Perioperative Protocol Goal Directed Therapy in Kidney Transplantation: Fluid Therapy Optimization and Impact on Postoperative Complications.

University of Catania1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Duration of hospitalization in a semi-intensive and intensive hospital ward.

研究概览

简要总结

In literature there is a huge amount of works demonstrating the direct correlation between volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major postoperative complications in patients with high cardiovascular risk and chronic renal failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that in certain populations with high surgical and post-operative complications risk, the adoption of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The current trend is therefore to guarantee greater precision in the intraoperative management of patients undergoing kidney transplantation from cadaver by using a specific protocol that can be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT), resulting from the adoption of an advanced minimally invasive hemodynamic monitoring technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively tested in an extensive case series of high perioperative risk patients underwent to major abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic surgery. In the present study there will be enrolled all patients who are candidates for kidney transplant from cadaver at the University Hospital "G. Rodolico" of Catania that meet the inclusion criteria of the study and will give their informed consent to participation. The enrolled patients will be monitored for a maximum period of 7 days from transplantation. As control group there will be considered an historical cohort of patients who underwent kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed according to the international guidelines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) Classification III-IV;
  • Age between 18 and 65 years;
  • First kidney transplantation from cadaver;
  • Absence of atrial fibrillation or severe arrhythmia;
  • Informed consent.

排除标准

  • Lack of informed consent;
  • Age less that 18 or greater than 65 years;
  • Atrial fibrillation and high frequency tachyarrhythmias;
  • Previous transplantation from cadaver.

结局指标

主要结局

Duration of hospitalization in a semi-intensive and intensive hospital ward.

时间窗: 7 days after transplantation

Frequency rate of postoperative complications

时间窗: 7 days after transplantation

The frequency rate of the subsequent postoperative complications in the two study cohort will be determined: early postoperative pulmonary complications (prolonged mechanical ventilation, failure acute respiratory disease, acute pulmonary edema, pulmonary infections); major cardiovascular complications (ischemic cardiac events and heart failure congestive); major surgical complications (anastomosis, delayed postoperative ileum, nausea and postoperative vomiting).

次要结局

  • Number of patients requiring hemodialysis in the two study cohorts(7 days after transplantation)
  • Number of patients with delayed graft failure in the two study cohorts(7 days after transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marinella Astuto

Principal Investigator

University of Catania

研究点 (1)

Loading locations...

相似试验