Randomized Controlled Trial of Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Composite of death or major postoperative complications
研究概览
简要总结
The primary aim of the study is to investigate whether a goal-directed resuscitation therapy in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces complications after cardiac surgery. The hypothesis is that there are better outcomes when achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate higher than 1.5 mmol/L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- •All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
- •Adults patients
- •Written informed consent
- •One of the following criteria:
- •EuroSCORE (European System for Cardiac Operative Risk Evaluation) higher than or equal to 6
- •Ejection fraction lower than 50%
- •Recent myocardial infarction
- •Unstable angina
排除标准
- •Age less than 18 years
- •Infectious endocarditis
- •Transplant procedures
- •Emergency procedures
- •Pulmonary hypertension
- •Preoperative cardiogenic shock or use of dobutamine
- •Congenital procedures
- •Need for intra-aortic balloon pump (IABP)
- •Noradrenaline dose higher than 1mcg/kg/min
- •Pregnancy
- •Patients who refused participation in the study
结局指标
主要结局
Composite of death or major postoperative complications
时间窗: within 30 days after cardiac surgery
Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.
次要结局
- Mechanical ventilation(within 30 days after cardiac surgery)
- Fluid balance(during ICU stay)
- Cardiovascular measures(within 30 days after cardiac surgery)
- Duration of ICU stay and hospital stay.(within 30 days after cardiac surgery)
- Tissue hypoperfusion markers(within 30 days after cardiac surgery)
研究者
Ludhmila Abrahão Hajjar
Supervisor of the Surgical Intensive Care Unit of the Heart Institute
University of Sao Paulo