NCT01758172已完成3 期
Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean arterial pressure
研究概览
简要总结
From postoperative patients having undergone pancreaticoduodenectomy;
- To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven
- To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient
- To compare the safety of the 2 intravenous colloids in the patient population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should be meet inclusion criteria to participated into the study
- •Age-from 18-75 years adult
- •In the immediate post-operative period of pancreaticoduodenectomy
- •Written informed consent and admitted ICU immediate post-operative patient
排除标准
- •Any patient meeting one or more of the following exclusion criteria may not be entered into the study.
- •Refusal to participate in the study
- •Evidence of pre-operative oliguria (Serum creatinine>1.5mmol/dL)
- •Known Severe congestive heart failure (NYHAIII,IV)
- •Known severe respiratory diseases (PaO2/FiO2 <200)
- •Known coagulopathy (Platelet<100k/mm3, aPTT>70s, PT(INR)>2.5)
- •Known allergy to hydroxyethyl starch
- •Known pregnancy or lactation
- •Has participated in any other clinical trial within 3months
- •Any contraindication to Voluven® or albumin according to their package inserts.
研究组 & 干预措施
Albumin
Active Comparator
albumin was administered to reach CVP up to 7mmHg
干预措施: Albumin (Drug)
6% hydroxyethyl starch 130/0.4
Experimental
6% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg
干预措施: 6% hydroxyethyl starch 130/0.4 (Drug)
结局指标
主要结局
Mean arterial pressure
时间窗: post-op 24hr
次要结局
- Volume(ml) of colloid(post-op 24hrs)
研究者
Song Cheol Kim
Principal Investigator
Asan Medical Center
研究点 (1)
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