跳至主要内容
临床试验/NCT03213574
NCT03213574撤回不适用

Impact of Goal Directed Fluid Therapy in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

Loma Linda University2 个研究点 分布在 1 个国家开始时间: 2017年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Postoperative ileus

研究概览

简要总结

Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

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

入选标准

  • Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management

排除标准

  • Age less than 18;
  • current pregnancy;
  • history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist;
  • patient refusal to consent

研究组 & 干预措施

Control Group

Active Comparator

The control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV.

干预措施: Control Group (Other)

Treatment Group

Experimental

The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm.

干预措施: Treatment Group (Other)

结局指标

主要结局

Postoperative ileus

时间窗: Up to 3 weeks postoperatively

Time postoperatively to first bowel movement

次要结局

  • Acute kidney injury(Up to 3 weeks postoperatively)
  • Respiratory compromise(Up to 3 weeks postoperatively)
  • Need for diuresis(Up to 3 weeks postoperatively)
  • Hospital length of stay(Up to 4 weeks postoperatively)

研究者

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

Ronak Raval

MD

Loma Linda University

研究点 (2)

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