Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,250
- 试验地点
- 21
- 主要终点
- Number of patients with acute kidney injury
研究概览
简要总结
Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.
详细描述
After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing cardiac surgery with planned cardiopulmonary bypass
- •Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned
- •Ability to provide informed consent (not incapacitated)
排除标准
- •Already on renal replacement therapy
- •Patients with chronic kidney disease defined as estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 [ CKD stage > 3 ]
- •Patients who are pregnant or lactating
- •Concurrent enrollment in another clinical trial
- •Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan
- •Patients with ongoing infections or current use of steroids
- •Patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. TEVAR)
研究组 & 干预措施
RESCAP®
Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion with a sum of 10,000 IU/day over the next 24 or 96 hours.
干预措施: RESCAP® (Drug)
Placebo
Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.
干预措施: placebo (Drug)
结局指标
主要结局
Number of patients with acute kidney injury
时间窗: 90 days
AKIN criteria: Rise in serum creatinine of by 0.3 mg/dl or 26 µmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of more than 50 percent or a drop in urine output to 0.5 ml/kg/hour for 6 hours
reach haemodynamic stability
时间窗: 7 days
Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability
次要结局
- cost-related outcome(30 days)
- levels of a set of inflammatory markers(4 days)