Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- base excess [mmol/l]
研究概览
简要总结
The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.
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 90 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
isotonic colloidal volume substitute
干预措施: Gelofusine balanced (Drug)
non-balanced gelatine solution
colloidal volume substitute
干预措施: Gelofusine 4% (Drug)
结局指标
主要结局
base excess [mmol/l]
时间窗: Change from baseline at end of surgery, an expected average of 2 hours surgery
chloride [mmol/l]
时间窗: Change from baseline at end of surgery, an expected average of 2 hours surgery
次要结局
- arterial blood gase analyses(until 12 hours after surgery)
- coagulation status(until 12 hours after surgery)
- renal function(until 12 hours after surgery)
- adverse events(until 12 hours after surgery)
- hemodynamics (systolic and diastolic blood pressure)(until 12 hours after surgery)
- time on ventilation(until 12 hours after surgery)