Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
研究概览
简要总结
The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery
详细描述
The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients ( 18 years old)
- •Written informed consent
- •Elective lung resection surgery (open or thoracoscopic lung lobectomy)
排除标准
- •Severe obesity
- •Moderate to severe aortic insufficiency
- •Renal failure requiring hemodialysis
- •Left ventricle ejection fraction less than 35 %
- •Urgent surgery
结局指标
主要结局
Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
时间窗: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.
To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2.
次要结局
- Tissue Perfusion Marker: Lactate(Within 24 hours after lung surgery)
- Oxygenation Marker: PaO2/FiO2 Ratio(Within 24 hours after lung surgery)
- Observation of Acute Respiratory Distress Syndrome (ARDS)(Within 30 days after lung surgery)
- Observation of Acute Kidney Injury (AKI)(After 72 hours of finalization of lung surgery)
- Tissue Perfusion Marker: SvcO2(Within 24 hours after lung surgery)
- Fluid Balance(After 24 hours of finalization of lung surgery)
- Duration of Hospital Stay(Within 30 days after lung surgery)
- Mortality(Within 30 days after lung surgery)