Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- serum NGAL level
研究概览
简要总结
Fluid management during neurosurgery presents a special clinical agenda. Volume overload can have detrimental effects on intracranial pressure by increasing either cerebral blood volume or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive fluid strategy may risk hemodynamic instability.
Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have been shown as a more precise parameters for fluid management including in neurosurgical patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy. Randomization will be generated by computer sampling. One of the two groups of patients will be managed with fluid bolus to keep intraoperative SVV <10% presenting the "normovolemia" group. The other group of patients will be kept intraoperative SVV <18% which is slightly above previously reported SVV threshold upper limit. The second group thus presents the "restrictive" group. Clinical outcomes, laboratory analysis including S100-B for neuronal damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be compared.
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
- Double (Participant, 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
- 否
入选标准
- •Supratentorial brain tumor receiving elective craniotomy
- •BMI between 18.5-27.0 kg.m-2
排除标准
- •Cardiac dysfunction, such as coronary artery diseases; atrial fibrillation;
- •NYHA class II
- •Renal dysfunction, eGFR< 60 ml.min-1.1.73m-2
- •Pulmonary cormorbidity, such as COPD
研究组 & 干预措施
Normovolemic group (keeping SVV<10% in supine; <15% in prone)
- The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 10% during the surgery to keep the normovolemia.
- If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.
- The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.
干预措施: Intravenous colloid bolus with Voluven (Drug)
Restricitve group (keeping SVV < 18% in supine; <23% in prone)
- The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 18% during the surgery to keep the normovolemia.
- If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.
- The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.
干预措施: Intravenous colloid bolus with Voluven (Drug)
结局指标
主要结局
serum NGAL level
时间窗: Changes from preoperative to postoperative day 2.
serum S100B protein
时间窗: Changes from preoperative to postoperative day 2
次要结局
- Total intraoperative intravenous fluid administrated(During the surgical time, an expected average of 3 to 5 hours)
- Length of hospital stay(participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks)
- Postoperative complications rate(participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks)