Examination of Safety and Efficacy of 6% Hydroxyethyl Starch 130/0.4 vs. 6% Hydroxyethyl Starch 70/0.5 in Patients Undergoing Orthopedic Surgery - a Double-blind, Parallel Group, Comparative, Multi-centre Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 7
- 主要终点
- Volume of colloid solution infused during investigational period (= intra-operatively)
研究概览
简要总结
The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
- •Patients with a body weight (BW) ≥ 50 kg
排除标准
- •Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
- •ASA classification ≥ IV
- •Renal disease (serum creatinine ≥ 2mg/dL)
- •Known bleeding disorders
- •Congestive heart failure
- •Fluid overload
- •Intracranial bleeding
- •Severe hypernatremia
- •Severe hyperchloremia
研究组 & 干预措施
1
Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
干预措施: 6% hydroxyethyl starch 130/0.4 (Drug)
2
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)
干预措施: 6% hydroxyethyl starch 70/0.5 (Salinhes®) (Drug)
结局指标
主要结局
Volume of colloid solution infused during investigational period (= intra-operatively)
时间窗: Intra-operatively
次要结局
- Fluid input(From immediately before induction of anesthesia until 48 hours after end of surgery)
- Fluid output(From immediately before induction of anesthesia until 48 hours after end of surgery)
- Fluid balance(From immediately before induction of anesthesia until 48 hours after end of surgery)
- Hemodynamics(From immediately before induction of anesthesia until 48 hours after end of surgery)
- Co-administration of vasoactive drugs(From enrolment until 48 hours after end of surgery)