NCT06710353招募中不适用
The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery: A Prospective Randomized Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- incidence of acute kidney injury (AKI)
研究概览
简要总结
The study aims to evaluate whether preoperative albumin supplementation in pediatric patients with hypoalbuminemia undergoing cardiac surgery can reduce inflammatory responses and prevent acute kidney injury (AKI) following cardiopulmonary bypass.
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
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass
- •Preoperative serum albumin level of 4.0 g/dL or lower
排除标准
- •abnormal preoperative creatinine level
- •history of dialysis
- •liver dysfunction
- •history of hypersensitivity to albumin
- •coagulation disorders
研究组 & 干预措施
Albumin group
Experimental
A 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction.
Control group
Placebo Comparator
The same volume of crystalloid solution as the administered albumin is infused.
结局指标
主要结局
incidence of acute kidney injury (AKI)
时间窗: assessed up to postoperative day 7
The difference in the incidence of acute kidney injury (AKI) between groups, as measured by the KDIGO criteria
次要结局
未报告次要终点
研究者
Ji-Hyun Lee
Associate Professor
Seoul National University Hospital
研究点 (1)
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