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临床试验/NCT02565420
NCT02565420已完成不适用

Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 8,616 人开始时间: 2015年9月28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
8,616
试验地点
1
主要终点
Major Post Operative Complications

研究概览

简要总结

Perioperative volumes of saline cause a mild acidosis compared with buffered fluids. On the other hand, saline administration maintains plasma osmolality and better repletes vascular volume which is an important goal of perioperative fluid administration. Currently, there is no convincing evidence that either saline or buffered solutions are preferable. Consequently, both types of fluid remain in common use at the Clinic and worldwide.

There has never been a large trial of perioperative saline and balanced salt solutions comparing the incidence of major complications including acute kidney injury. The investigators primary objective is thus to determine the relative safety of perioperative saline and lactated Ringer's solution. Specifically, the investigators propose to test the:

  1. Primary hypothesis that a composite of major in-hospital postoperative complications is lower in patients given lactated Ringer's solution compared to normal saline.
  2. Secondary hypothesis that acute kidney injury, measured by AKIN criteria, is lower in patients given lactated Ringer's solution compared to normal saline.

The acquisition cost of saline and lactated Ringer's solutions is similar in the United States. (Curiously, buffered solutions are far more expensive than saline in Great Britain.) But to the extent that one fluid or the other provokes more complications, cost of care may be increased with that fluid selection. Cost may also be increased by the need for additional electrolyte monitoring and electrolyte replacement.

The investigators will therefore secondarily conduct an economic evaluation to determine the relative incremental hospital cost of each fluid. To the extent that one fluid or the other reduces cost (assuming similar complication rates), the Clinic will be able to reduce cost by specifying the appropriate fluid without impairing quality.

Evidence that one fluid or the other causes few complications would be a strong quality indicator that the Clinic should standardize perioperative fluid selection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Patients having colorectal or similar surgery
  • •Patients having orthopedic or similar surgery
  • •Patients 18 years and older

排除标准

  • •Patients under 18 years of age

研究组 & 干预措施

Lactated Ringer's solution

Active Comparator

During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of Lactated Ringer's solution fluids.

干预措施: Lactated Ringer's solution (Other)

normal saline

Placebo Comparator

During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of normal saline solution.

干预措施: Normal saline (Other)

结局指标

主要结局

Major Post Operative Complications

时间窗: After surgery through hospital discharge

Major complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications.

次要结局

  • Economic evaluation(After surgery through hospital discharge)

研究者

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

Kamal Maheshwari, MD MPH

Principal Investigator

The Cleveland Clinic

研究点 (1)

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