Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 584
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury after surgery
研究概览
简要总结
Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.
详细描述
Sepsis, defined as life-threatening organ dysfunction, is caused by a dysregulated host response to infection, which 30-day mortality rate is about 24.4%. Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids.
Surgical patients with septic shock are not rare. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction, furthermore exacerbate hemodynamic instability, and then increase the incidence of AKI and patient mortality. Therefore, to improve cardiac function in patients with septic shock who received general anesthesia is the key to save patients life and improve prognosis.
The latest international guidelines for the treatment of septic shock recommend - in patients with septic shock combined with cardiac dysfunction, treatment with norepinephrine in combination with dobutamine is recommended if inadequate tissue perfusion persists after adequate fluid resuscitation and maintenance of blood pressure, but the level of evidence is weak.
Dobutamine acts on β-adrenergic receptors, which can improve tissue perfusion, and small doses of 2.5-5ug/kg/min can increase myocardial contractility and improve cardiac function in patients without increasing heart rate. Previous study has demonstrated that the combined use of norepinephrine and dobutamine can elevate left ventricular ejection fraction, cardiac index, improve tissue perfusion, and reduce mortality in patients with septic shock. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.
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
- None
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 with 18 years or older
- •Sugery patients with septic shock and the duration of opration is more than 1 hour
排除标准
- •Long-term intakeβ-receptor blocker;
- •patietns with dobutamine used within 72h before enrollment;
- •Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 72h before enrollment;
- •Patients with hyperthyroidism;
- •Allergy or known sensitivity to catecholamines（norepinephrine, dobutamine etc.）and genera anesthetics.
- •Patients and guardians refused to participate in this intervention clinical trial.
研究组 & 干预措施
Dobutamine, norepinephrine
Patients will be initiated on Dobutamine at 5 mcg/kg/min while continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 65mmHg or more
干预措施: Dobutamine (Drug)
Dobutamine, norepinephrine
Patients will be initiated on Dobutamine at 5 mcg/kg/min while continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 65mmHg or more
干预措施: Norepinephrine (Drug)
Norepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Incidence of acute kidney injury after surgery
时间窗: within 1 week after surgery
Incidence of acute kidney injury after surgery
Sequential Organ Failure Assessment (SOFA) score
时间窗: Day 1 Day 3 and Day 7 in ICU after surgery
Sequential Organ Failure Assessment (SOFA) score, ranges from 0 to 24, with 24 being the worst
Mortality
时间窗: in hospital and Day 28 and Day 90 after the surgery
Mortality
次要结局
- Lactate level measurement(before surgery (0 hour), 1hour after begining of surgery and at the end of surgey)
- capillary filling time(before surgery (0 hour), 1hour after begining of surgery and at the end of surgey)
- Central venous oxygen saturation (ScvO2)(before surgery (0 hour), 1hour after begining of surgery and at the end of surgey)
- Urine volume(1hour after begining of surgery and at the end of surgey)
- Duration of norepinephrine intraoperatively(intraoperatively)
- Cumulative dose of norepinephrine intraoperatively(intraoperatively)
- Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia(intraoperatively)
- Postoperative complication(through study completion, an average of 1 year)
- Length of hospital stay after sugery(through study completion, an average of 1 year)
- ICU-free days with 28 days postoperatively(28 days postoperatively)
- Duration of mechanical ventilation in ICU(through study completion, an average of 1 year)
- Renal replacement therapy(through study completion, an average of 1 year)
- Duration of renal replacement therapy(through study completion, an average of 1 year)
- ICU-Mortality(through study completion, an average of 1 year)
- In-hosipital Mortality(through study completion, an average of 1 year)
- Hospitalization costs(through study completion, an average of 1 year)
研究者
xiangming fang
professor
First Affiliated Hospital of Zhejiang University