2024-511153-21-00招募中4 期
Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a multicenter, prospective, randomized, controlled study
Fakultni Nemocnice Brno3 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年6月11日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.
研究概览
简要总结
The primary objective of the clinical trial is to determine the effect of GDHT guided by the non-invasive Starling™ SV System on the incidence of postoperative complications in patients undergoing neurosurgical intervention.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Elective brain surgery with an expected duration ≥ 2 h
- •Category 1-3 according to the ASA Physical Status Classification
- •Lateral or supine operative position
- •Signed the relevant informed consent form
排除标准
- •Category 4 according to the ASA Physical Status Classification
- •Surgery for traumatic brain injury or acute hemorrhagic stroke
- •Awake brain surgery
- •Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)
- •Unavailability of hemodynamic monitoring data
- •Cardiac arrhythmia with irregular cardiac rhythm
- •Known hypersensitivity to the active substance or to any of the excipients of IMP
- •Pregnancy and lactation
结局指标
主要结局
Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.
Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.
次要结局
- Duration of surgery, LOS, ICU LOS, 28-day mortality, descriptive analysis of the incidence of any adverse events and reactions
- MAP, HR, SVV, number of episodes of hypotension, number of vasopressor administrations
- Hemoglobin, plasma lactate level
- Volume of blood loss, urinary output, number of administered units of packed RBC, number of subjects receiving transfusion, crystalloid and colloid solutions consumption, boluses of crystalloids
研究者
Ondřej Hrdý
Scientific
Fakultni Nemocnice Brno
研究点 (3)
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