Liberal Versus Restrictive Dobutamine in Cardiac Surgery (DOBUTACS): a Prospective Randomized Non-inferiority Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Combined endpoint of arrhythmias (ventricular and supraventricular), acute myocardial infarction, stroke or transient ischemic attack, low-output syndrome, cardiogenic shock and death from all causes within 30 days after cardiac surgery
研究概览
简要总结
Inotropic agents are usually administered in the postoperative period after cardiac surgery. In most cases, dobutamine is administered routinely, for the probable occurrence of myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal evidence of altered tissue perfusion.
Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the perioperative period. However, the use of inotropic agents may be associated with adverse events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect.
This study is a non-inferiority clinical randomized study aiming to compare the use of dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output syndrome associated with altered tissue perfusion). Our primary hypothesis is that the restrictive use of dobutamine is as safe and effective as the liberal one.
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)
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
- •Patients undergoing cardiac surgery of coronary artery bypass graft (CABG) with cardiopulmonary bypass;
- •Age equal or greater than 18 years;
- •Written informed consent.
排除标准
- •Previous ventricular dysfunction (ejection fraction lower than 50%)
- •Sustained supraventricular or ventricular arrhythmias;
- •Cardiogenic shock or need for inotropes before surgery;
- •Immediate need of ventricular assist device or intraaortic balloon after CPB;
- •Combined procedure;
- •Pregnancy;
- •Participation in another study.
研究组 & 干预措施
Liberal dobutamine group
All patients will receive dobutamine at the cardiopulmonary bypass weaning
干预措施: Liberal dobutamine protocol (Drug)
Restrictive dobutamine group
Patients will only receive dobutamine if they present clinical signs of cardiogenic shock
干预措施: Restrictive dobutamine protocol (Drug)
结局指标
主要结局
Combined endpoint of arrhythmias (ventricular and supraventricular), acute myocardial infarction, stroke or transient ischemic attack, low-output syndrome, cardiogenic shock and death from all causes within 30 days after cardiac surgery
时间窗: 30 days
次要结局
- Mortality rate(30 days)
- Acute myocardial infarction incidence(30 days)
- Stroke incidence(30 days)
- Cardiogenic shock(30 days)
- ICU and hospital length of stay(30 days)
- Low cardiac output syndrome(30 days)
- Cardiac arrhythmias(30 days)
- Days free of mechanical ventilation(30 days)
- Severe sepsis and septic shock(30 days)
- SOFA score within 72 hours(72 hours)
研究者
Ludhmila Abrahão Hajjar MD, PhD
Professor
University of Sao Paulo