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临床试验/NCT04137042
NCT04137042已完成不适用

Comparison Between 0.9% Saline and Balanced Crystalloid on Intraoperative Metabolomic Profiles Among Patients Undergoing Major Spine Surgery: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年3月25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
入组人数
56
试验地点
1
主要终点
Changes of metabolites in serum and urine measured by metabolomic mass spectrometry

研究概览

简要总结

Different crystalloids, namely 0.9% saline and balanced crystalloid may result in different metabolomic profile among surgical patients. This study aims to investigate the serum and urine profiles between patients undergoing major spine surgery using 0.9% saline and balanced crystalloid.

详细描述

Intravenous fluid is mandatory for acute and critically ill patients as well as for surgical patients. Two crystalloid iv. solutions namely 0.9% saline and balanced crystalloid are the most commonly administrated. However, early literature suggests that 0.9% saline is associated with hyperchloremic acidosis, which affects cellular metabolism and may result in worse prognosis among acute or critically ill patients. However, recent literature in 2018, including a meta-analysis and a large randomized controlled trial published in the New England Journal of Medicine revealed neutral or merely slight different clinical outcomes between 0.9% saline and balanced crystalloids. Therefore, the metabolic differences between these two fluids may only exist in specific metabolic pathway which may be easily masked by the complex pathophysiological changes in acute and critically ill patients. These metabolic alteration may be only identified by precise research t the technology such as liquid chromatography mass spectrometry, which provides more comprehensive metabolomics profiles. By comparison, surgical patients undergoing major spine surgery receive a relatively large amount of intravenous infusion during surgery, and there is not complicated with complex pathophysiological alteration of cormorbid diseases. Accordingly, this study aim to identify the metabolomic differences between 0.9% saline and balanced crystalloid among patients undergoing major spine surgery by using the liquid chromatography mass spectrometry technique.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Balanced crystalloid

Experimental

intraoperative fluid therapy by using balanced crystalloid

干预措施: Balanced crystalloid (Drug)

Saline

Active Comparator

intraoperative fluid therapy by using 0.9% saline

干预措施: Saline (Drug)

结局指标

主要结局

Changes of metabolites in serum and urine measured by metabolomic mass spectrometry

时间窗: 2-6 hours

Serum and urine samples will be collected twice (before and immediately after surgery) in each patient.

次要结局

  • Intraoperative arterial blood gas profile(2-6 hours)
  • Intraoperative hemodynamic stability(2-6 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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