EUCTR2019-001131-31-DK进行中（未招募）1 期
Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in patients with septic shock induced endotheliopathy – a multicentre randomized, placebo-controlled, blinded, investigator-initiated trial”
Section for transfusion Medicines, Capital Region Blood Bank, Copenhagen University Hospital0 个研究点目标入组 380 人开始时间: 2019年3月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
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
- •1. Adult intensive care patients (age = 18 years)
- •2. Septic shock, defined as (i) suspected or documented infection, (ii) persisting hypotension requiring vasopressors to maintain MAP =65 mm Hg AND a lactate level >2 mmol/L despite fluid therapy
- •3. sTM > 10 ng/mL
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Withdrawal from active therapy
- •2. Pregnancy (non-pregnancy confirmed by patient having a negative urine- or plasma hCG or being postmenopausal defined as females at 60 years old and beyond or at the investigators discretion)
- •3. Known hypersensitivity to iloprost or to any of the other ingredients.
- •4. Life-threatening bleeding as defined by the treating physician
- •5. Known severe heart failure (NYHA class IV)
- •6. Suspected acute coronary syndrome
- •7. Previously included in this trial
- •8. Screening > 12 hours after diagnosis of septic shock
- •9. Informed consent cannot be obtained
- •10. Included in clinical trials with prostacyclin within the last 90 days
研究者
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