NCT01127477已完成3 期
Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study
Fresenius Kabi Japan8 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Volume Effect
研究概览
简要总结
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing major elective surgery
- •Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg
- •Adult patients: Routine measurement of Central Venous Pressure (CVP)
排除标准
- •Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
- •ASA classification ≥ IV
- •Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
- •Known bleeding disorders
- •Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.
结局指标
主要结局
Volume Effect
时间窗: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery
Volume effect will be assessed by evaluating the following parameter: 1. Saved albumin: For adult patients: Amount of 6 % hydroxyethyl starch 130/0.4 (HES130) administered during surgery once 1000 mL of HES130 are exceeded. For pediatric patients: Amount of HES130 administered during surgery once 10 mL HES130/kg body weight are exceeded. 2. Time course of hemodynamic stability
次要结局
- Fluid Balance(From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery)
- Hemodynamics(From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery)
- CVP(Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery)
- Hematology(One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery)
- Clinical Chemistry(One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery)
- Hemostasis(One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery)
- Body Temperature(One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery)
- ECG(Screening, 2 hours and 24 hours after end of surgery)
- Urinalysis(Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery)
- Local and Systemic Tolerance(After each administration of study drug)
- (Serious) Adverse Events(From signing informed consent until 28 days follow up)
研究者
研究点 (8)
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