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临床试验/NCT03881332
NCT03881332已完成不适用

Clinical Observational Study Using Iohexol to Measure Perioperative Glomerular Filtration Rate in Patients Undergoing Robotic Surgery for Rectum or Large Bowel Cancers

University Hospital of North Norway1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4
试验地点
1
主要终点
Glomerular filtration rate

研究概览

简要总结

Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

详细描述

The considerable morbidity and mortality associated with perioperative acute kidney injury (AKI) is well documented and known to complicate recovery from surgery.

Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to monitor perioperative onset of rapidly changing renal function. This may subsequently lead to design of randomized controlled trials examining the effects of earlier intervention with the aim to reduce the incidence of perioperative AKI.

Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data also showed that the continuous infusion protocol of low-dose iohexol is an accurate and precise method when measuring changing GFR even in critical ill patients with variable AKI risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research questions related to perioperative change in renal function.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rectum or colon cancer

排除标准

  • Acute kidney injury grade 3 or higher

结局指标

主要结局

Glomerular filtration rate

时间窗: 72 hours

Measured glomerular filtration rate

次要结局

未报告次要终点

研究者

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

Lars Marius Ytrebo

Professor

University Hospital of North Norway

研究点 (1)

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