Efficacy and Safety of 6 % Hydroxyethyl Starch 130/0.4 (Voluven®) vs. 5% HSA in Volume Replacement Therapy During Elective Open-heart Surgery in Paediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Total Volume of Colloid Solution Required Intraoperatively
研究概览
简要总结
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
详细描述
In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many settings. This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement therapy during elective open-heart surgery in paediatric patients. The hypothesis of this study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy and provide comparable safety during elective open-heart surgery in paediatric patients 2 to 12 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC;
- •Signed parental written informed consent and patient assent where achievable
排除标准
- •Known contraindication against scheduled concomitant medication;
- •Total ECC volume < 400 mL;
- •ASA > III
研究组 & 干预措施
1
Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)
干预措施: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) (Drug)
2
Control drug: Human serum albumin (HSA 50g/L)
干预措施: Human serum albumin (HSA 50g/L) (Drug)
结局指标
主要结局
Total Volume of Colloid Solution Required Intraoperatively
时间窗: Day 1 (intraoperatively)
Total volume of study drug plus rescue colloid, if applicable
次要结局
- Mean Arterial Pressure (MAP)(Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU))
- Fluid Input(2 days)
- Fluid Output(2 days)
- Fluid Balance(2 days)