Effects of Intraoperative Goal-directed Fluid Therapy (GDFT) on the Postoperative Brain Edema in Neurosurgical Patients With Malignant Supratentorial Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Quantitative analysis of brain edema
研究概览
简要总结
Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative brain image indicating high-grade glioma (HGG), verified by postoperative histology of the World Health Organization (WHO) as grade III or IV tumors.
- •Age 18-65 years, and American Society of Anaesthesiologists (ASA) physical status I to III.
- •Signed informed consent.
排除标准
- •Renal insufficiency or the creatinine clearance is < 30 mL/kg.
- •Heart disease, New York Heart Association Functional Classification (NYHA) class II or higher heart failure, or if their cardiac ejection fraction is < 20%.
- •Chronic obstructive pulmonary disease.
- •Extensive peripheral arterial occlusive disease.
- •Coagulopathy.
- •Surgery in the prone position.
- •Recurrent carcinoma or tumor in the brain ventricular.
- •Body Mass Index <18.5 kg·m-2 or >30.0 kg·m-
- •Awake craniotomy.
结局指标
主要结局
Quantitative analysis of brain edema
时间窗: Within 24 hours postoperatively
Postoperative brain edema is defined as edema surrounding the surgical resection cavity, which will be evaluated through CT images.Image evaluators will manually delineate region of interest (ROI) and operative cavity on each slice. The area will be calculated automatically by PACS system. The total volume will be acquired by multiplying area and slice thickness. The volume of edema will be calculated by the totoal volume of edema plus cavity minus the volume of cavity.
次要结局
- The incidence of delirium(During the first 3 postoperative days)
研究者
Yuming Peng
Ph.D.,M.D.
Beijing Tiantan Hospital