Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The UK ANDROMEDA-SHOCK-2 Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- organ support
研究概览
简要总结
The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care.
详细描述
Septic shock is a life-threatening condition caused by a severe infection. It can rapidly cause multi-organ failure and is associated with a high risk of dying. Patients with septic shock need emergency treatment with intravenous fluids, antibiotics and medications to improve blood supply to all organs. However, it is clear that giving too much fluid is harmful and giving not enough fluid can make organ failure worse, too. International guidelines exist but there is still a lot of variation in how doctors apply the guideline. Further, it is likely that a "one-size-fits-all" approach does not help all patients.
Previously, the Andromeda-Shock 1 trial showed that resuscitation guided by regular monitoring of skin perfusion was associated with a lower risk of dying than resuscitation guided by regular blood tests. The UK Andromeda-Shock-2 RCT builds on this. The aim is to investigate whether an individualised approach based on monitoring of skin perfusion combined with individualised treatment of the blood pressure and circulation for 6 hours is better for patients with septic shock and reduces the risk of organ failure and dying compared to usual care.
During the study period, the investigators will also take a total of 40ml of blood and 60ml of urine for special kidney tests to evaluate kidney health and recovery of kidney function.
After the study has finished, the investigators plan to share fully anonymised results with the investigators of the international Andromeda Shock 2 trial to get as much information as possible to answer the research question and help patients in future.
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
- •Consecutive adult patients (≥ 18 years) with septic shock defined by Sepsis-3 consensus criteria. (ie septic shock defined as suspected or confirmed infection, hyperlactatemia and noradrenaline requirement, after a fluid load of at least 1000mL in 1 hour)
排除标准
- •Any of the following criteria preclude participation to the trial:
- •More than 4 hours since septic shock diagnosis,
- •Surgery or acute renal replacement therapy anticipated to start during the 6h intervention period
- •Active bleeding,
- •Child B-C Cirrhosis
- •Underlying disease process with a life expectancy <90 days
- •Attending clinician deems aggressive resuscitation unsuitable
- •Refractory shock (high risk of death within 24h)
- •Concomitant severe acute respiratory distress syndrome
- •Capillary refill time cannot be accurately assessed
结局指标
主要结局
organ support
时间窗: 28 days
time to cessation of vital organ support
hospital mortality
时间窗: 28 days
number of patients who died in hospital
length of stay
时间窗: 28 days
length of stay in hospital
次要结局
- mortality(60 days)
- length of stay(60 days)
- vital organ support(28 days)