Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- lactate and creatinine level
研究概览
简要总结
Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central venous pressure (CVP), guidance results in better clinical outcomes.
Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine level.
Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP guidance.
Outcome analyses: Compare serum lactate, creatinine as well as other postoperative complications between both groups.
详细描述
Objective
To compare postoperative clinical outcome in adult patient undergoing EVAR.
Primary outcome: Postoperative serum lactate and creatinine.
Secondary outcome: Postoperative complications.
Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid management protocol. SVV group will be managed according to stroke volume variation (SVV) protocol, i.e., control SVV 10-13% and give fluid when SVV > 13%. CVP group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg.
Outcome analyses: Postoperative serum lactate and creatinine of both groups will be compared using unpaired Student-t test. Secondary outcomes will be compared using chi-square test.
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)
盲法说明
The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-80 years old
- •Patient had aortic aneurysm both thoracic and abdominal types
- •Scheduled for elective EVAR procedures
- •New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
- •Body mass index (BMI) 18-24 kg/m2
- •Provided informed consent before surgery
排除标准
- •Scheduled for emergency or redo surgery
- •Received prior fluid therapy (>2,500 ml/day over the 48 h before the surgery)
- •Presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases
- •Preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months
- •Difficulty (or contraindication to) placing a central venous catheter
- •Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
- •Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency
研究组 & 干预措施
SVV group
Fluid management protocol
干预措施: Fluid management protocol (Procedure)
CVP group
Fluid management protocol
干预措施: Fluid management protocol (Procedure)
结局指标
主要结局
lactate and creatinine level
时间窗: at the end of surgery up to 48 hours
serum lactate and creatinine level
次要结局
未报告次要终点
研究者
Thepakorn Sathitkarnmanee
Associate Professor
Khon Kaen University