Early Goal Directed Therapy vs Standard Protocol for Hemodynamic Management in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of inotropic/vaso active drugs requirement
研究概览
简要总结
Early goal directed therapy (EGDT) based on information from arterial waveform derived cardiac output (APCO) FloTrac/EV1000 system has been proved to improve postoperative outcomes in patients undergoing major surgery. This system, however, has the limitation to be applied in open-chest surgery, especially cardiac surgery. The efficiency of FloTrac/EV1000 system to improve postoperative outcomes in cardiac surgery is still inconclusive.
Hypothesis: Intraoperative management in patients undergoing cardiac surgery guided by FloTrac/EV1000 system, compared with conventional protocol, results in better clinical outcomes.
Primary outcomes: Immediate postoperative inotropic/vasoactive drugs requirement.
Methods: Adult patients undergoing cardiac surgery will be randomized into 2 groups: EGDT group managed by FloTrac/EV1000 system and Control group managed by conventional protocol.
Outcome analyses: Compare the number of inotropic/vasoactive drugs requirement at the end of surgery, as well as intensive care unit (ICU) stay between both groups.
详细描述
Objective
To compare postoperative clinical outcome in adult patients undergoing cardiac surgery.
Primary outcome: Postoperative inotropic/vasoactive drugs reqirement.
Secondary outcome: ICU stay.
Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid and inotropic/vasoactive drugs management protocol. EGDT group will be managed according to information derived from FloTrac/EV1000 system, i.e., control stroke volume variation (SVV) 10-13% and give fluid when SVV > 13%, give inotropic to maintain cardiac index (CI) 2.5-4 L/min/m2, and give vasoactive drugs to maintain systemic vascular resistance index (SVRI) of 1,900-2,400 dynes-sec/cm-5/m2 . Control group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg, give inotropic/vasoactive drugs according to blood pressure and heart rate as well as clinical signs at the discretion of attending anesthesiologists.
Outcome analyses: Postoperative number of inotropic/vasoactive drugs requirement as well as ICU stay of both groups will be compared using unpaired Student-t test or Mann-Whitney U 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Patient has ischemic or valvular heart disease
- •Scheduled for elective cardiac surgery
- •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
- •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
结局指标
主要结局
Number of inotropic/vaso active drugs requirement
时间窗: up to Day 1 postoperatively
number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate
次要结局
- ICU stay(up to day 10 postoperatively)
- Lactate level(up to Day 1 postoperatively)
- Creatinine level(up to day 10 postoperatively)
研究者
Thepakorn Sathitkarnmanee
Associate professor
Khon Kaen University