The Effect of Intraoperative Goal Directed Restricted Fluid Therapy Guided by Stroke Volume Variation Versus Standard Fluid Therapy on Extravascular Lung Water in Major Abdominal Operations: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Extravascular lung water (Lung ultrasound score)
研究概览
简要总结
The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.
详细描述
Perioperative fluid management has an important impact on patient outcome. Under-resuscitation leads to hypoperfusion and over-resuscitation leads to tissue oedema. Intraoperative goal directed fluid therapy (GDT) has been reported to improve patient outcome in high risk surgical patients. GDT aims to optimize oxygen delivery through various strategies. The main three GDT strategies are:
- Stroke volume optimization with fluids
- Stroke volume variation (SVV) and pulse pressure variation (PPV) optimization with fluids.
- Oxygen delivery index with fluids and inotropes Although GDT was recommended by professional societies in Europe and United Kingdom, these recommendations were recently challenged in many randomized controlled trials and meta-analysis.The effect of GDT on intraoperative fluid requirements was previously reported, however; its effect on extravascular lung water is not well studied.
Electrical cardiometry is a recent non-invasive technology for cardiac output measurement. Electrical cardiometry drive CO measurement from thoracic electrical bioimpedance. Good correlation was reported between CO measurements derived from electrical cardiometry and continuous thermodilution monitoring system.
Although many protocols for GDT have been reported in major abdominal operations, till now there is no consensus about the optimum protocol nor the optimum goals to achieve during fluid management. Major abdominal operations are characterized by major fluid shifts. Moreover, patients undergoing these operations are prone to impaired organ functions due to tissue oedema. Traditional standard care in major abdominal operations usually includes 6 ml/Kg/h balanced crystalloids (to restore insensible losses and maintenance requirements) in addition to replacement of blood losses. We hypothesize that the use of a more restricted fluid approach (2ml/Kg/h) + GDT guided by cardiometry will improve fluid management and decrease extra-vascular lung water.
The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients scheduled for major abdominal operations
排除标准
- •Patients with arrhythmias, pulmonary hypertension or impaired cardiac contractility.
- •Patients with impaired liver or kidney function.
- •Patients with BMI above 40.
研究组 & 干预措施
Restricted fluid therapy group
Patients will receive restricted fluid management guided by concomitant SVV monitoring. GDT protocol
干预措施: Restricted fluid therapy group (Procedure)
Control group
Patients will receive standard fluid management.
干预措施: Standard fluid management (Procedure)
结局指标
主要结局
Extravascular lung water (Lung ultrasound score)
时间窗: Lung ultrasound will be performed in the postoperative care unit 30 minutes after patient recovery
Lung ultrasound with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China). Lung ultrasound will be assessed for the presence of B lines. The B line is the name given to an artifact with seven features: a hydroaeric comet-tail artifact; arising from the pleural line; hyperechoic; well defined; spreading up indefinitely; erasing A lines; and moving with lung sliding when lung sliding is present. The lung ultrasound score was obtained by scanning 12-rib interspaces with the probe longitudinally applied perpendicular to the wall. Each hemi-thorax was divided in six areas: two anterior areas, two lateral areas, and two posterior areas. The sum of B-lines found on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score from 0 to 36.
次要结局
- Intraoperative fluid requirement(intraoperatively)
研究者
Ahmed Hasanin
Lecturer of anesthesia and critical care medicine
Cairo University