Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative Acute Kidney Injury
研究概览
简要总结
The goal of this randomized controlled trial is to test if a hyperosmolar prime solution used for cardiopulmonary bypass increases the risk for acute postoperative kidney injury.
详细描述
Two-hundred cardiac surgical patients were randomised into two groups based on the osmolality level of the prime solution used for cardiopulmonary bypass. The high osmolality group (966 mOsm) received a prime solution containing Ringer-Acetate 1000 ml + Mannitol 400 ml (60 g) + Sodium-Chloride 40 ml (160 mmol) and Heparin 2 ml (10 000 IU), while the reference group with normal osmolality (388 mOsm) received a prime solution containing Ringer-Acetate 1400 ml and Heparin 2 ml (10 000 IU).
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)
盲法说明
Priming of the heart-lung machine performed by a staff member not affiliated to the study protocol.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass.
排除标准
- •Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.
研究组 & 干预措施
HighOsmo
This group received a priming solution with high osmolality
干预措施: HighOsmo (Drug)
结局指标
主要结局
Postoperative Acute Kidney Injury
时间窗: Three days
Defined according to the KDIGO definition
次要结局
未报告次要终点