Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 26
- 主要终点
- The change of peripheral vascular resistance
研究概览
简要总结
Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (iNOS) and prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. However, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. At this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.From the perspective of Chinese medicine, shock is a disease of yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This trial was designed to give patients with septic shock the use of Shenfu injection to determine the specific effects of Shenfu injection on vascular reactivity in patients with septic shock.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as septic shock according to 2016 SSC Guidelines;
- •The dose of norepinephrine required to maintain MAP>65mmHg ≥0.5μg/kg.min;
- •SVRI <800 dyns/cm5.m2;
- •CI>2.5L/min/m2;
- •The patient or the patient's family signed the informed consent form for this trial.
排除标准
- •septic shock occurs more than 24 hours;
- •Age > 85 years old or <18 years old;
- •pregnant or lactating women;
- •There are shock patients caused by other causes such as cardiogenicity and neurogenicity;
- •The terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.
研究组 & 干预措施
placebo group
5% GS solution
干预措施: shenfu injection (Drug)
control group
shenfu injection
干预措施: shenfu injection (Drug)
结局指标
主要结局
The change of peripheral vascular resistance
时间窗: day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3
次要结局
- Diastolic blood pressure(day 1, day 2, day 3)
- Dosage of vasoactive drugs(day 1, day 2,day 3)
研究者
Jianfeng Xie
physician, sponsor-investigator,clinical professor
Southeast University, China