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
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- • Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group.
研究概览
简要总结
First primary endpoint Demonstrate that RESCAP® intervention reduces the time to reach stability, while at ICU. Severity of illness is assessed using the SOFA (Sequential Organ Failure Assessment) score over 12 days while the patient remains in the ICU. Outcome will be compared after 72 hours in the ICU.
Second primary composite endpoint Demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass as defined by the 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 ≥50 percent 10 or • A drop in urine output to 0.5 ml/kg/hour for 6 hours Occurrence of acute kidney injury will be checked within 30 days and additionally after 90 after surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •> 21 years of age (legal adult in Singapore)
- •Undergoing cardiac surgery with planned cardiopulmonary bypass
- •EuroSCORE II >= 3
- •Ability to provide informed consent (not incapacitated)
- •Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol.
排除标准
- •Already on renal replacement therapy
- •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.
- •Patients who are pregnant or lactating
- •Concurrent enrolment in another clinical trial
- •Known allergic reaction to bovine alkaline phosphatase
- •Patient with ongoing infections or current use of steroids
- •Patient with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g., TEVAR)
结局指标
主要结局
• Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group.
• Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group.
• Stop if all cause mortality, cardiac mortality, acute kidney injury, or the primary compound outcome is significantly higher in the experimental group
• Stop if all cause mortality, cardiac mortality, acute kidney injury, or the primary compound outcome is significantly higher in the experimental group
• Stop if more than 5% of patients have a serious adverse/allergic reaction to the administration of the drug
• Stop if more than 5% of patients have a serious adverse/allergic reaction to the administration of the drug
次要结局
未报告次要终点
研究者
Dr. Ruud Brands
Scientific
Alloksys Life Sciences B.V.