CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 186
- 试验地点
- 38
- 主要终点
- Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB)
研究概览
简要总结
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
详细描述
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline definition of acute kidney injury when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery. The objective of using CytoSorb® treatment in this setting is to provide clinically meaningful improvements in renal function by mitigation of intraoperative injury by removal of nephrotoxic agents such as pfHb and complement. Up to 420 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for non-emergent cardiac surgery requiring CPB for i) heart valve replacement with any other procedure, without hypothermic circulatory arrest (HCA), or ii) aortic reconstruction with or without another procedure, with HCA
排除标准
- •Isolated Coronary Artery Bypass Graft
- •Pregnant women
- •Life expectancy of < 14 days
- •End stage organ disease
- •Active infection
- •Correction of a congenital heart defect
- •Contraindication to anticoagulation with heparin
- •Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve replacement (TAVR)
- •Declined informed consent
结局指标
主要结局
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB)
时间窗: From start of CPB through 48 hours after CPB
Incidence and severity of AKI in the first 48 hours after CPB, evaluated based on creatinine levels at CPB, 24 \& 48h after CPB and urine output up to 48h.
次要结局
- Summary of Health Resource Utilization: ICU Duration (Hours)(From start of CPB through discharge, average of 8.9 days.)
- Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission(From start of CPB through discharge, average of 8.9 days.)
- Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication(From start of CPB through discharge, average of 8.9 days.)
- Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use(From start of CPB through discharge, average of 8.9 days.)
- Initiation of Renal Replacement Therapy(Up to 48 hours after CPB)