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临床试验/NCT03249298
NCT03249298已完成不适用

Comparison of Crystaloids and Colloids for Fluid Optimization in Patients Undergoing Neurosurgical Procedure

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Consumption of optimisation fluid

研究概览

简要总结

Fluid optimization in neurosurgical patients has an important impact on preservation of cerebral perfusion pressure and minimization of cerebral oedema during and after the craniotomy. The investigators would like to know if crystalloids or colloids are equally useful for goal directed therapy in this patients. The investigators will record haemodynamic stability, volume loading and postoperative complications and compare two groups of patients. One group will be optimised with crystalloids and the second with colloids. The investigators will compare also hospital stay and mortality in the two groups.

详细描述

Hemodynamic stability and maintenance of cerebral perfusion pressure (CPP) are important in neurosurgical patients. Fluid management includes maintenance of intravascular volume, preservation of cerebral perfusion pressure and minimization of cerebral oedema. Fluid management of the neurosurgical patient has advanced from "run them dry" to "run them isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by current strategies are still unknown. Advanced techniques provide goal directed fluid therapy which is currently the gold standard in fluid strategy. In patients undergoing craniotomy diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding may lead to hypovolemia and poor cerebral perfusion. On the other hand fluid overload increases complications and hospital stay after surgery. It is, therefore, important that optimal fluid levels are achieved.

The aim of the study was to compare intraoperative hemodynamic stability, volume loading and postoperative complications between group optimised with crystalloids and group optimised with colloids in patients undergoing neurosurgical procedure. The investigation will include 80 patients, 40 optimised with crystalloids and 40 with colloids.

Hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality will be monitored during and aftre the surgery.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neurosurgery (tumour, vascular, adenoma), haemodynamic stability

排除标准

  • arrhythmia

研究组 & 干预措施

Crystalloids

Active Comparator

Bolus of crystalloids

Bolus of 250 ml crystaloids will be infused regarding the measures

干预措施: Sterofundin (Bolus of crystalloids) (Drug)

Colloids

Active Comparator

Bolus of colloids

Bolus of 250 ml colloids will be infused regarding the measures

干预措施: Voluven (Bolus of colloids) (Drug)

结局指标

主要结局

Consumption of optimisation fluid

时间窗: During surgery

Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid

次要结局

  • Postoperative complications(From the first day until 15 day after the surgery)

研究者

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

Jasmina Markovic Bozic

MD, PhD

University Medical Centre Ljubljana

研究点 (1)

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