Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
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:
- Primary hypothesis that a composite of major in-hospital postoperative complications is lower in patients given lactated Ringer's solution compared to normal saline.
- 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
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
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
Kamal Maheshwari, MD MPH
Principal Investigator
The Cleveland Clinic
