EUCTR2021-005358-28-ES进行中(未招募)1 期
Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2) - ANDROMEDA-SHOCK-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Consecutive adult patients (= 18 years) with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- More than 4 hours since septic shock diagnosis
- •- Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period
- •- Active bleeding
- •- Do not resuscitate status
- •- Child B-C Cirrhosis
- •- Underlying disease process with a life expectancy < 90 days and/or the attending clinician deems aggressive resuscitation unsuitable
- •- Refractory shock (high risk of death within 24h)
- •- Pregnancy
- •- Concomitant severe acute respiratory distress syndrome.
- •- Patients in whom CRT cannot be accurately assessed
研究者
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