The Comparison Between Early Norepinephrine Use and Standard Treatment During Severe Sepsis and Septic Shock Resuscitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Therapeutic goal achievement
研究概览
简要总结
Current septic shock guideline recommends fluid resuscitation as the first treatment. Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid therapy. This can cause a certain duration of systemic hypotension before vasopressor is commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of septic shock may increase blood pressure quicker than start treatment with intravenous fluid alone. The rapid restoration of perfusion pressure may improve septic shock outcome.
详细描述
We will include severe infection patient who had evidence of organ dysfunction and hypotension and randomize into 2 groups as following:
- Control group. The patient will receive treatment according to septic shock guideline 2013, which start with intravenous fluid replacement until achieve target central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP) or other fluid responsive test goal. If the patient's mean arterial blood pressure still lower than 65 mmHg, then norepinephrine or dopamine will initiate to rise blood pressure. The patient will receive 5% dextrose water as the placebo of norepinephrine.
- Early norepinephrine group. The patient will receive fluid therapy together with low dose of norepinephrine (0.05 mcg/kg/min). If after titrate intravenous fluid therapy until achieve goal CVP or PCWP or other fluid responsive test, but the mean blood pressure still lower than 65 mmHg, then additional titrate dose of norepinephrine will be given to the patient according to standard septic shock guideline.
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
- •Age > or = 18 years old
- •Diagnosed severe sepsis or septic shock according to survival sepsis campaign 2013
- •Mean arterial pressure < 65 mmHg
排除标准
- •Pregnancy
- •Severe underlying condition that unexpected to survive more than 48 hours
- •Severe peripheral vascular disease
- •Patient who required major surgery within 24 hours
研究组 & 干预措施
Early norepinephrine
Norepinephrine 4 mg in 5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour, adjusted according to patient's body weight to achieve norepinephrine 0.05microgram/kg/min Continuous drip for 48 hours.
干预措施: Early norepinephrine (Drug)
Placebo
5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour. Adjust rate of infusion according to patient's body weight to achieve dosage of norepinephrine comparable to 0.05 microgram/kg/min Continuous drip for 48 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Therapeutic goal achievement
时间窗: 6 hours
Therapeutic goal including 1. Mean arterial blood pressure \> or = 65 mmHg 2. Evidence of adequate tissue perfusion which include continuation of urine output \> or = 0.5 ml/kg/hour for 2 hours or decreasing of serum lactate \> or = 10 percent in 1 to 2 hours.
次要结局
- Mortality rate(28 days)