EUCTR2016-002663-33-AT进行中（未招募）1 期
Preventing Oxidative stress-induced Ischemic Injury and Systemic Inflammation complications during and after invasive Cardiac surgery with Alkaline Phosphatase (APPIRED III) - APPIRED III
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,250
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
- •A potential subject must meet all of the following criteria to participate in the study:
- •1.> 21 years of age (legal adult in Singapore)
- •2.Undergoing cardiac surgery with planned cardiopulmonary bypass
- •3.EuroSCORE II >= 3
- •4.Ability to provide informed consent (not incapacitated)
- •5. Patient has given written informed consent prior to participation in the trial and
- •undertakes to comply with the protocol.
- •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 625
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 625
排除标准
- •Any subjects meeting the following criteria at baseline will be excluded:
- •1.Already on renal replacement therapy
- •2.Patients with chronic kidney disease defined as urinary albumin excretion of =30 mg/day, or equivalent or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2 for > 3 months.
- •3.Patients who are pregnant or lactating.
- •4.Concurrent enrolment in another clinical trial
- •5.Known allergic reaction to bovine alkaline phosphatase
- •6. Patient with ongoing infections or current use of steroids
- •7. Patient with high-risk emergency surgery or with follow-up procedures already
- •planned at admission (like e.g., TEVAR)
研究者
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