NCT02808325已完成3 期
Prospective Controlled Randomized Double-blind Multicentre Study in Parallel Groups on the Efficacy and Safety of Gelaspan in Combination With Sterofundin ISO in Comparison With Gelofusine in Combination With Sodium Chloride Braun in Patients Scheduled for Abdominal or Pelvic Surgery
B. Braun Medical LLC3 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Base Excess
研究概览
简要总结
It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
balanced gelatine solution
Experimental
isotonic colloidal volume substitute
干预措施: Gelaspan 4% (Drug)
non-balanced gelatine solution
Active Comparator
colloidal volume substitute
干预措施: Gelofusine 4% (Drug)
结局指标
主要结局
Base Excess
时间窗: Change in base excess from baseline to end of surgery
次要结局
- Arterial blood gas analysis(until 12 hours after end of surgery)
- Coagulation status(until 12 hours after end of surgery)
- Base Excess(Change in base excess from baseline to 12 hours after end of surgery)
- Renal Function(until 12 hours after end of surgery)
- Hemodynamics(until 12 hours after end of surgery)
- Adverse events(until 12 hours after end of surgery)
研究者
研究点 (3)
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