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临床试验/NCT03429127
NCT03429127Unknown不适用

Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery

Clinical Hospital Centre Zagreb1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年3月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Changes in acid base pH status

研究概览

简要总结

The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.

详细描述

Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients with brain tumor, meningeomas and vascular malformation.

排除标准

  • Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease

结局指标

主要结局

Changes in acid base pH status

时间窗: During operation and immediately after operation

Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid

次要结局

  • Changes in electrolytes (sodium and chloride)(During operation and immediately after operation)

研究者

发起方
Clinical Hospital Centre Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasa Kovac

Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist

Clinical Hospital Centre Zagreb

研究点 (1)

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