临床试验/NCT01855542

NCT01855542已完成不适用

The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.

Yonsei University2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2012年3月最近更新: 2013年5月16日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Yonsei University
入组人数: 50
试验地点: 2
主要终点: base-excess

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 20 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.

排除标准

•ASA class III or IV
•breast feeding
•lack of mental weakness(including disabled)
•using diuretics
•respiratory insufficiency
•metabolic acidosis or alkalosis
•coagulation disorder
•over hydtration
•renal failure or serum creatinine > 1.4mg/dl
•anemia (Hemoglobin 9.0<mg/dl)
•hypernatremia (Na > 145mEq/L)
•Hyperkalemia (K>5.5mEq/L)
•psychological medication or any drugs that influences renal clearance

结局指标

主要结局

base-excess

时间窗: Change from baseline in base-excess at postoperative 12 h

次要结局

未报告次要终点

研究者

发起方

Yonsei University

申办方类型

Other

责任方

Sponsor

研究点 (2)

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