Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 15
- 主要终点
- 28 Day mortality
研究概览
简要总结
Catecholamines infusion is a major component of septic shock management. International guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III trials are lacking. The present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.
详细描述
The french Conference on Consensus on catecholamines use in septic shock has underlined the importance of carrying out a clinical trial to clarify the use of epinephrine, norepinephrine and dobutamine in the management of multiple organ failure associated with severe sepsis. The main objective of the study was therefore to compare the effects of the combination of dobutamine and norepinephrine to those of epinephrine alone in patients with septic shock. In this purpose, patients were randomly assigned to receive either epinephrine or norepinephrine plus dobutamine and drugs were titrated to maintain blood pressure over 70 mmHg. Main outcome was 28-day mortality.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adults over 18 years
- •Informed consent
- •Presenting from less than 7 days :
- •One or more infectious site
- •At least 2 of the following criteria: temperature > 38°C or < 36.5°C, respiratory rate > 20 breaths per min or PaCO2 < 32 mmHg or mechanical ventilation, heart rate > 90 beats/min, white blood cell count > 12,000/mm3 or < 4,000/mm3
- •At least 2 of the following criteria: PaO2/FiO2 ratio <280 mmHg (if mechanical ventilation, urinary output of less than 0.5 mL/kg of body weight or < 30 mL/h at least 1 hour, plasma lactate > 2 mmol/L, platelet count < 100,000 /mm3
- •And presenting from at least 24 hours:
- •Systolic blood pressure < 90 mmHg or mean blood pressure < 70 mmHg (for at least 30 min);
- •1000 mL fluid replacement or pulmonary capillary wedge pressure > 12 mmHg
- •Dopamine infusion at 15 µg/kg/min for at least 1 hour, or epinephrine or norepinephrine in first intention
排除标准
- •Pregnant woman
- •Obstructive cardiomyopathy
- •Acute coronary disease
- •Non infectious shock
- •Care limitation
- •White blood cell count < 500 /mm3
研究组 & 干预措施
1
norepinephrine plus dobutamine
干预措施: norepinephrine and dobutamine (Drug)
2
epinephrine
干预措施: epinephrine plus placebo of dobutamine (Drug)
结局指标
主要结局
28 Day mortality
时间窗: 28 Day
次要结局
- -28-day survival distribution(Day 28)
- -Survival rate at days 14, 28, 90, 6 months and 1 year.(one year)
- -Rate of patients with secondary care limitation(one year)
- -Organ failure between randomization and day 28.(Day 28)
- -Serious adverse events between randomization and exit of intensive care unit.(one year)
- -Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia)(one year)
- -Time on vasopressors(Day 90)
- -Time in intensive care unit(one year)
- -Time in hospital(one year)
- -Costs(Day 90)