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临床试验/NCT03446196
NCT03446196已完成不适用

Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

University of Padova1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Urine output in the first hour post unclamping (ml) in the two groups

研究概览

简要总结

There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.

The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.

详细描述

Renal transplantation is actually considered the optimal elective treatment for end stage kidney disease.

Successful renal transplantation involves the optimization of several parameters. Previous studies have suggested that perioperative hemodynamic factors influence immediate and long-term graft survival.

Perioperative hemodynamic management of this kind of surgery is nowadays focused on optimization of fluid therapy concerning both the donor and the graft and their interaction. Postoperative graft function is not exclusively determined by donor and graft characteristics. Several studies over the last 30 years indeed demonstrated that hemodynamic status of the recipient during kidney transplant surgery relates to graft function and proper management of balancing fluid plays a critical role through maintaining optimal blood volume and so assure an adequate supply of oxygen to the tissues.

Aggressive expansion of the intravascular volume during transplantation surgery has been recommended by most previous studies supporting the so called "liberal" approach to fluid management suggesting that a massive intravascular volume expansion was necessary improve renal blood flow and minimize hypoperfusion caused tissue damages. Nowadays it is clear that adequate early graft function requires perfusion of the transplanted kidney, which may be enhanced by expansion of the intravascular volume in the recipient. However, some studies have reported that aggressive intraoperative volume expansion is not always warranted in kidney transplantation and can expose patients with preexistent cardiac disease or poor myocardial function to the risk of fluid overload, acute respiratory failure, and prolonged ventilation. Moreover fluid overload has been demonstrated to be harmful even for graft perfusion, microcirculation and tissue oxygen delivery.

There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Written informed consent Renal transplantation candidate

排除标准

  • •Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

研究组 & 干预措施

CLINICIAN EXPERIENCE

No Intervention

Fluid replacement will be made based on clinician experience

MOSTCARE UP

Experimental

Clinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12%

干预措施: Fluid replacement based on MOSTCARE up (Device)

结局指标

主要结局

Urine output in the first hour post unclamping (ml) in the two groups

时间窗: first hour post unclamping during kydney transplanation

Urine output in the first hour post unclamping (ml) in the two groups

次要结局

  • 1) Urine output in the first 24h (ml)(24hour)
  • 2) Need for haemodialysis in the first week (% of patients)(7 days)
  • 3) First week creatinine and urea trend in the two groups(7 days)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro De Cassai

Medical Doctor

University of Padova

研究点 (1)

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