NL-OMON53204尚未招募3 期
se of mechanical left ventricular unloading in acute decompensated systolic heart failure complicated by cardiogenic shock - UNLOAD HF-CS
Amsterdam UMC0 个研究点目标入组 154 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Evidence of HFrEF according to ESC HF guidelines, (LVEF <= 35%)
- •2. Signs of (persistent) congestion (elevated CVP, edema, rales)
- •3. Evidence of CS with presence of at least 2 of the 3 following
- •a. hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <60
- •b. oliguria (<= 0,5 ml/kg/h, <= 720 ml/24 h, lactate > 2 mmol/L,creatinine rise >=
- •0.3 mg/dl during first
- •24h ( 26,53 µmol/L, amino-L-transferase >200 U/L)
- •c. inotropes/vasoactive (use of)
- •4. Age 18-75 y
排除标准
- •1. Cardiovascular
- •a. Contraindications for Impella CP
- •b. Severe concomitant RV failure
- •c. Contraindications for inotropic usage
- •d. Dialysis for end-stage renal failure
- •e. Acute coronary syndrome during admission
- •2. Medical history
- •a. History of CVA or TIA within previous 90 days
- •b. History of acute myocardial infarction within previous 30 days
- •c. History of bleeding diathesis
- •3. Inflammatory
- •a. Active systemic infections, sepsis
- •4. General
- •a. Patient has other medical, social, or psychological problems
- •b. Patient belongs to a vulnerable population
研究者
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