跳至主要内容
临床试验/NCT03949036
NCT03949036已完成不适用

Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation: A Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月1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
60
试验地点
2
主要终点
serum neutrophil-gelatinase-associated lipocalin (NGAL)

研究概览

简要总结

The investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.

详细描述

The adequate preload target of fluid management has not yet been established during kidney transplantation. Traditionally, sufficient intravascular volume status has been recommended to maintain perfusion to renal graft. Stroke volume variation was reported to be superior to the traditional target of central venous pressure. In this regard, the investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The patients do not know which group they will be enrolled. The outcome assessor will be blind to the group assignment of the participants.

入排标准

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

入选标准

  • Adults patients who are undergoing living donor kidney transplantation with continuous radial artery pressure monitoring

排除标准

  • Patients who have cardiac arrhythmia of atrial fibrillation, multiple ventricular premature complex
  • Cardiac systolic dysfunction with left ventricle ejection fraction <50%
  • Continuous arterial pressure monitoring at the site other than radial artery.
  • Patients who are considered to be intolerant to rapid fluid administration

结局指标

主要结局

serum neutrophil-gelatinase-associated lipocalin (NGAL)

时间窗: at the end of surgery

urine biomarker of renal injury

次要结局

  • Delayed graft function determined by the incidence of hemodialysis(during the first postoperative week)
  • Immediate graft function(after eight days after surgery)
  • serum neutrophil-gelatinase-associated lipocalin (NGAL)(at the anesthesia induction procedure)
  • Delayed graft function determined by glomerular filtration rate(during the 24 hours after surgery)
  • Delayed graft function determined by urine output (less than 1200 ml)(during the first postoperative day)
  • Delayed graft function determined by serum creatinine(during the 48 hours after surgery)
  • Incidence of postoperative bleeding(during the first postoperative week)
  • hospital length of stay(the first postoperative month)
  • Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)(during the 10 days after surgery)
  • slow graft function(after eight days after surgery)
  • Incidence of pneumonia(during the first postoperative week)
  • Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)(during the first postoperative week)
  • serum creatinine value(seventh postoperative day)
  • Incidence of wound infection(during the first postoperative week)

研究者

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

Won Ho Kim, MD

Associate Professor

Seoul National University Hospital

研究点 (2)

Loading locations...

相似试验

Comparison of Two Different Preload Targets of... | 临床试验