NCT02631356Unknown4 期
The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery
First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The patient's arterial blood viscosity (mpa.s) as tested by viscometer
研究概览
简要总结
The study is to investigate the effect of succinylated gelatin on the blood viscosity and oxygen delivery in patients during surgeries, so as to have a better understanding of the safety in the use of succinylated gelatin for surgical patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18 years and 60 years
- •ASA physical status I and II
- •surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring
排除标准
- •Patients younger than 16 y or older than 60 y
- •Body Mass Index (BMI) <18 or >30
- •Allergy to any of the drugs used
- •Severe cardiovascular dysfunction
- •Patient refusal
研究组 & 干预措施
Ringer's lactate solution
Placebo Comparator
Infusion of Ringer's lactate solution (10ml/kg) in the control group
干预措施: Ringer's lactate solution (Drug)
Succinylated gelatin
Active Comparator
Infusion of Succinylated gelatin (10ml/kg) in the test group
干预措施: Succinylated gelatin (Drug)
结局指标
主要结局
The patient's arterial blood viscosity (mpa.s) as tested by viscometer
时间窗: up to 5 months (after the infusion of succinylated gelatin )
次要结局
- The patient's oxygen delivery index (DO2I) as calculated by Vigileo(up to 5 months (after the infusion of succinylated gelatin ))
研究者
Feng Xia
Professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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